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Bipolar Disorder trial readouts

registry pull 2026-08-19

Primary-completion dates that listed drug and biotech companies filed with ClinicalTrials.gov for studies in Bipolar Disorder. They are the sponsor's own estimated windows, revised as a study runs — not announcement dates. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Upcoming readout windows

next 180 days · by month

3 studies across 3 companies, in the next 180 days.

September 2026 1

TickerNameStudyPhaseStatusPrimary completionReadout inUpdated
ALKSAlkermes, Inc.Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I DisorderNCT05303064Change from baseline in body mass index (BMI) Zscore at week 12Phase 3RecruitingSep 2026≤ 41 d2026-08-14

December 2026 1

TickerNameStudyPhaseStatusPrimary completionReadout inUpdated
ALZNAlzamend Neuro, Inc.A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I DisorderNCT07540338To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.Phase 1/2RecruitingDec 2026≤ 133 d2026-07-28

January 2027 1

TickerNameStudyPhaseStatusPrimary completionReadout inUpdated
NBIXNeurocrine BiosciencesA Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) InhibitorNCT07105111Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24Phase 4RecruitingJan 2027≤ 164 d2026-06-16

Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.

Every registered study in Bipolar Disorder

most recently updated first

137 studies match. Showing the first 100 of 137 studies — page through, or narrow the filters.

TickerNameMarket capStudyPhaseStatusInterventionsConditionsEnrollmentStartPrimary completionReadout inUpdated
ALKSAlkermes, Inc.$8.3BLong-term Safety Extension Study of OLZ/SAM in Pediatric SubjectsNCT04987229Incidence of adverse eventsPhase 3Enrolling by invitationDrug: OLZ/SAMBipolar I Disorder, Schizophrenia2362021-10-22Sep 2027≤ 406 d2026-08-14
ALKSAlkermes, Inc.$8.3BStudy to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I DisorderNCT05303064Change from baseline in body mass index (BMI) Zscore at week 12Phase 3RecruitingDrug: OLZ/SAM, OlanzapineSchizophrenia, Bipolar I Disorder2202022-06-30Sep 2026≤ 41 d2026-08-14
ABBVAbbVie$457.5BA Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II DisorderNCT06696755Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total scorePhase 2RecruitingDrug: Icalcaprant, Placebo for IcalcaprantBipolar I Disorder, Bipolar II Disorder1952026-02-03Nov 2027≤ 467 d2026-08-14
BTAIBioXcel Therapeutics Inc$25MDexmedetomidine in the Treatment of Agitation Associated With Bipolar DisorderNCT04276883results2023-09-11Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total ScorePhase 3CompletedDrug: Sublingual film containing Dexmedetomidine (BXCL501), Placebo FilmAgitation Associated With Bipolar Disorder, Agitation,Psychomotor, Bipolar Disorder3802020-02-242020-05-21actual2026-08-11
BTAIBioXcel Therapeutics Inc$25MDetermining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar DisorderNCT05025605Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total scorePhase 1RecruitingDrug: BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 MicrogramsSchizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II1402021-08-272027-07-31in 345 d2026-08-11
BTAIBioXcel Therapeutics Inc$25MTachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar DisorderNCT06041646results2026-01-02Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total ScorePhase 4CompletedDrug: Sublingual film containing IgalmiBipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder, Schizophreniform Disorders292023-10-022024-04-29actual2026-08-11
RAPPRapport Therapeutics Inc.$2.4BStudy Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I DisorderNCT07046494Young Mania Rating Scale (YMRS)Phase 2Active, not recruitingDrug: RAP-219 · Other: PlaceboBipolar 1 Disorder2532025-07-252026-08-05actual2026-08-10
BTAIBioXcel Therapeutics Inc$25MDexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)NCT05658510Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total scorePhase 3CompletedDrug: BXCL501, Matching PlaceboAgitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders4522022-11-212025-08-15actual2026-08-07
ABBVAbbVie$457.5BA Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Adult Participants With Bipolar DisorderNCT07071532Maximum Plasma Concentration (Cmax) of ABBV-932 and active metabolites DCAR and DDCARPhase 1Not yet recruitingDrug: ABBV-932, ItraconazoleBipolar Disorder202026-08-21Feb 2027≤ 192 d2026-08-06
BTAIBioXcel Therapeutics Inc$25MAssessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar DisorderNCT07116694Informant and Clinician ratings comparisonPhase 2CompletedDrug: BXCL501 Sublingual FilmBipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Psychomotor Agitation332025-06-192025-10-07actual2026-08-06
LLYEli Lilly and Company$1.15TA Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)NCT07286175Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse CriterionPhase 2RecruitingDrug: Brenipatide, PlaceboBipolar Disorder4002025-11-24Nov 2027≤ 467 d2026-08-06
ALKSAlkermes, Inc.$8.3BAn Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)NCT07744113expanded accessAvailableDrug: OLZ/SAMBipolar 1 Disorder, Schizophrenia Disorder2026-08-04
NBIXNeurocrine Biosciences$15.7BAn Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current ManiaNCT07288320Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Day 21Phase 2RecruitingDrug: NBI-1117568, PlaceboBipolar I Disorder, Mania1502025-12-24Feb 2028≤ 558 d2026-07-31
ALZNAlzamend Neuro, Inc.$8MA Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I DisorderNCT07540338To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.Phase 1/2RecruitingDrug: AL001, Lithium carbonateBipolar I Disorder202026-05-11Dec 2026≤ 133 d2026-07-28
ABBVAbbVie$457.5BA Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.NCT04777357Number of Participants with Adverse EventsPhase 3RecruitingDrug: Cariprazine, PlaceboDepression, Bipolar I Disorder3802021-04-28Mar 2027≤ 223 d2026-07-27
LBRXLB Pharmaceuticals Inc.$1.5BMulticenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.NCT07494305Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10)Phase 2RecruitingDrug: LB-102 · Other: PlaceboBipolar I Disorder3202026-01-23Feb 2028≤ 558 d2026-07-27
BMYBristol-Myers Squibb$134.9BA Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or LamotrigineNCT07140913Change from baseline in Young Mania Rating Scale (YMRS) at Week 5Phase 3RecruitingDrug: Xanomeline/Trospium Chloride, PlaceboMania, Bipolar Disorder4242025-10-082027-06-28in 312 d2026-06-23
NBIXNeurocrine Biosciences$15.7BA Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) InhibitorNCT07105111Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24Phase 4RecruitingDrug: ValbenazineSchizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia502025-08-29Jan 2027≤ 164 d2026-06-16
XENEXenon Pharmaceuticals Inc.$6.1BA Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)NCT07172516Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6.Phase 3RecruitingDrug: Azetukalner, PlaceboBipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder4002025-08-08Jun 2028≤ 680 d2026-06-03
XENEXenon Pharmaceuticals Inc.$6.1BAn Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)NCT07217860Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interestPhase 3Enrolling by invitationDrug: AzetukalnerBipolar Depression, Bipolar I Disorder, Bipolar Disorder, Bipolar II Disorder4002025-10-30Jun 2029≤ 1,045 d2026-06-03
ABBVAbbVie$457.5BObservational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I DisorderNCT06256367observationalChange From Baseline on Montgomery-Åsberg Depression Rating Scale (MADRS) Total ScoreCompletedBipolar I Disorder1202024-04-182026-01-23actual2026-02-24
NBIXNeurocrine Biosciences$15.7BStudy of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive DyskinesiaNCT05859698results2026-01-16Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24Phase 4CompletedDrug: ValbenazineSchizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder, Tardive Dyskinesia592023-05-092024-12-27actual2026-01-16
ABBVAbbVie$457.5BStudy of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II DisorderNCT06605599Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total ScorePhase 2CompletedDrug: ABBV-932, Placebo for ABBV-932Bipolar I Disorder, Bipolar II Disorder1612024-10-152025-11-12actual2026-01-12
ABBVAbbVie$457.5BOpen-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum DisorderNCT04578756Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment PeriodPhase 3CompletedDrug: Cariprazine Flexible Dose, Cariprazine Flexible DoseSchizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD)3102021-02-012025-10-06actual2025-10-27
VNDAVanda Pharmaceuticals$329MPharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State ConditionsNCT06494397Bioequivalence between VHX-896 tablets relative to iloperidone tabletsPhase 1CompletedDrug: VHX-896 and iloperidone, Iloperidone and VHX-896Schizophrenia, Bipolar I Disorder262024-07-112024-10-24actual2025-09-19
VNDAVanda Pharmaceuticals$329MSafety and Tolerability of Open-Labeled Iloperidone in AdolescentsNCT05648591Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.Phase 4RecruitingDrug: IloperidoneSchizophrenia, Bipolar I Disorder1002023-05-242026-03-312025-03-04
4503.TAstellas Pharma Inc$26.0BLong-term Study of FK949E in Elderly Bipolar Disorder PatientsNCT01737268results2017-10-31Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total ScorePhase 3CompletedDrug: FK949EBipolar Disorder, Elderly202012-10-292016-06-29actual2024-11-19
4503.TAstellas Pharma Inc$26.0BA Study to Evaluate the Efficacy of FK949E in Bipolar Disorder Patients With Major Depressive EpisodesNCT01725308results2017-02-08Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total ScorePhase 2/3CompletedDrug: FK949E, PlaceboBipolar Disorder4312012-02-072015-08-01actual2024-11-15
4503.TAstellas Pharma Inc$26.0BStudy to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive EpisodesNCT02362412results2017-03-17Montgomery-Asberg Depression Rating Scale (MADRS) Total ScorePhase 3CompletedDrug: FK949EBipolar Depression222015-02-182016-02-06actual2024-11-15
4503.TAstellas Pharma Inc$26.0BA Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar DisorderNCT03403790observationalSafety assessed by incidence of serious adverse eventsCompletedDrug: QuetiapineDepression, Bipolar Disorder3692018-01-152020-03-19actual2024-10-16
ALKSAlkermes, Inc.$8.3BStudy to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831NCT03201757results2024-09-26Incidence of Adverse EventsPhase 3CompletedDrug: ALKS 3831Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder5232017-06-152023-09-06actual2024-09-26
ABBVAbbVie$457.5BStudy to Assess Accuracy of Rapid Mood Screener in Adult Participants With Unipolar Major Depressive Disorder or Bipolar 1 Disorder in Real World SettingNCT05956483observationalPositive Predictive Value (PPV) of Rapid Mood Screener (RMS)CompletedBipolar I Disorder4232023-12-042024-08-16actual2024-08-20
OGNOrganon and Co$3.6B9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)NCT00143182Maintenance of the effect (Asenapine comparable to olanzapine in terms of the reduction of symptoms achieved in the short term (ie. 3 week studies [A7501004 or A7501005]) as measured on the Young Mania Rating ScalePhase 3CompletedDrug: Asenapine, OlanzapineBipolar Disorder5042005-01-072006-06-28actual2024-08-15
OGNOrganon and Co$3.6B3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)NCT00159744Changes in bipolar manic or mixed symptoms reflected in the scores on the YMRS (Young Mania Rating Scale)Phase 3CompletedDrug: Asenapine, Olanzapine, PlaceboBipolar Disorder4882004-11-302006-04-29actual2024-08-15
OGNOrganon and Co$3.6B3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)NCT00159796Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total ScorePhase 3CompletedDrug: Asenapine, Olanzapine, PlaceboBipolar Disorder4892004-12-142006-03-28actual2024-08-15
OGNOrganon and Co$3.6BFixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)NCT00764478results2015-04-24Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21Phase 3CompletedDrug: Asenapine, Asenapine, PlaceboBipolar 1 Disorder3672012-04-062014-04-30actual2024-06-18
OGNOrganon and Co$3.6BA Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)NCT01206517results2012-12-21Maximum Plasma Concentration (Cmax) of AsenapinePhase 1CompletedDrug: Asenapine 2.5 mg, Asenapine 5 mg, Asenapine 10 mgSchizophrenia, Bipolar I Disorder302010-07-182011-08-04actual2024-05-23
OGNOrganon and Co$3.6BExtension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)NCT01349907results2015-03-09Number of Participants Who Experienced Clinical or Laboratory Adverse EventsPhase 3CompletedDrug: Asenapine, Rescue medicationBipolar Disorder3222011-06-162014-09-05actual2024-05-22
OGNOrganon and Co$3.6B12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)NCT00145470results2019-09-16Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21Phase 3CompletedDrug: Asenapine, PlaceboBipolar Disorder3262005-06-022007-02-28actual2024-05-21
VNDAVanda Pharmaceuticals$329MEvaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I DisorderNCT04819776results2024-04-16Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total ScorePhase 3CompletedDrug: Iloperidone, Iloperidone PlaceboBipolar I Disorder4172021-03-222022-09-07actual2024-04-18
NVSNovartisThe Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.NCT00154323Duration of remissionPhase 4CompletedDrug: OxcarbazepineBipolar Disorder55Jan 2003Jan 2006actual2023-12-14
BIIBBiogen$31.4BA Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive EpisodeNCT03692910results2022-04-20Part A: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)Phase 2CompletedDrug: SAGE-217, PlaceboBipolar Disorder I, Bipolar Disorder II, Major Depressive Episode352018-08-232019-05-21actual2023-12-13
ALKSAlkermes, Inc.$8.3BPhase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I DisorderNCT04987658Maximum plasma concentration observedPhase 1CompletedDrug: OLZ/SAMBipolar I Disorder72021-07-222023-08-11actual2023-11-22
ABBVAbbVie$457.5BA Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed FeaturesNCT03573297results2023-09-28Time to First Relapse of Any Mood Episode During the Double-Blind Treatment PeriodPhase 3CompletedDrug: Cariprazine, PlaceboBipolar I Disorder, Mania, Depression9012018-06-152022-09-05actual2023-09-28
ALKSAlkermes, Inc.$8.3BStudy to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I DisorderNCT03187769results2023-01-19Percent Change From Baseline in Body Weight at Week 12Phase 3CompletedDrug: ALKS 3831, OlanzapineSchizophrenia, Schizophreniform Disorders, Bipolar I Disorder4262017-06-082021-12-01actual2023-01-19
OGNOrganon and Co$3.6B40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)NCT00159783results2010-07-16Participants Who Experienced Adverse Event(s)Phase 3CompletedDrug: asenapine, OlanzapineBipolar Disorder218Jul 2005Apr 2007actual2022-02-09
OGNOrganon and Co$3.6B40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)NCT00145509results2010-04-16Number of Participants Who Experienced an Adverse EventPhase 3CompletedDrug: Asenapine, PlaceboBipolar Disorder77Aug 2005Dec 2007actual2022-02-08
OGNOrganon and Co$3.6BPost-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)NCT01495741observationalNumber of Participants with Bipolar Disorder with Identified and Potential Clinically Important RisksCompletedBipolar Disorder, Schizophrenia422013-07-012017-12-18actual2022-02-04
OGNOrganon and Co$3.6BAn Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)NCT01498770observationalFrequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or GreaterCompletedDrug: Asenapine, Aripiprazole, Quetiapine, Risperidone, Olanzapine, Ziprasidone, Iloperidone, Paliperidone, Lurasidone, Clozapine, Amisulpride, Sertindole, ZotepineBipolar Disorder422013-04-012017-12-21actual2022-02-04
BWAYBrainswaySafety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar DepressionNCT01566591HDRS-21 Score measured by change from baseline.Not applicableUnknown statusDevice: Deep TMS Treatment, Sham TreatmentBipolar Depression120May 2012Dec 20212021-02-04
VNDAVanda Pharmaceuticals$329MEvaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or SchizophreniaNCT04127058The frequency of treatment-emergent adverse events as measured by the number of eventsPhase 1CompletedDrug: IloperidoneBipolar I Disorder, Schizophrenia122019-10-072019-11-27actual2020-04-13
AZNAstraZenecaPredictors of Recurrence in Bipolar Disorder in SpainNCT00690859observationalOnset of mood disorders episodes (depression, mania, hypomania and mixed) during the 1 year follow-up periodCompletedBipolar Disorder595Jun 2007Mar 2009actual2020-01-22
OPKOPKO Health, Inc.$1.0BSafety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I DisorderNCT01674010results2015-10-12Treatment Emergent Adverse EventsPhase 2Terminatedsponsor's stated reason: Business DecisionDrug: ELND005, Lamotrigine, Valproic acid, PlaceboBipolar 1 Disorder309Aug 2012Jun 2014actual2019-10-21
BIIBBiogen$31.4BSafety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.NCT00908154Safety and tolerability will be evaluated by monitoring AEs and concomitant medication, ECG, Lead II monitoring, Holter monitoring, vital signs, and laboratory parameters.Phase 1CompletedDrug: Placebo, GSK1014802Bipolar Depression, Bipolar Disorder512008-05-312008-12-31actual2017-10-30
BIIBBiogen$31.4BGSK Drug Single Dose Escalation And Their Effect On Resting Motor Threshold In Healthy VolunteersNCT00488566Part1:AEs for the duration of the study;Phase 1CompletedDrug: GSK drug · Other: Placebo, LamictalBipolar Disorder502007-05-312008-05-31actual2017-10-26
NVSNovartisOpen Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I DisorderNCT00139594Safety and tolerability of treatment with licarbazepine over 52 weeks.Phase 4CompletedDrug: licarbazepineBipolar Disorder181Dec 2004Jul 2007actual2017-03-28
NVSNovartisAn Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I DisorderNCT00238485Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.Phase 3CompletedDrug: LicarbazepineBipolar I Disorder251Jan 2005Jul 2007actual2017-03-28
NVSNovartisAn Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.NCT00228059Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.Phase 3CompletedDrug: LicarbazepineBipolar I Disorder132Jan 2005Jul 2007actual2017-02-23
AZNAstraZenecaEvaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar DepressionNCT01256177results2016-02-03Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total ScorePhase 3CompletedDrug: Quetiapine Fumarate (SEROQUEL) Extended Release, PlaceboBipolar Depression361Dec 2010Nov 2012actual2016-04-15
AZNAstraZenecaObservation Study of the Clinical Management of Bipolar DisorderNCT01770704observationalNumber of episodes (depression, mania, hypomania or mixed).CompletedBipolar Disorder520Feb 2013Jul 2014actual2016-04-07
AZNAstraZenecaEvaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar DisorderNCT01663974observationalThe prevalence of sub-syndromal symptoms after an acute depressive episode in Bipolar Disorder patients, as measured by scoring on YMRS and MADRS scales and MVAS-BP self-administered questionnaire.TerminatedBipolar Disorder, Sub-syndromal Symptoms125Apr 2013Dec 2013actual2015-03-09
LLYEli Lilly and Company$1.15TStudy in Adolescents With Schizophrenia or Bipolar DisorderNCT00982020results2014-12-17Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All ParticipantsPhase 4CompletedDrug: Olanzapine · Behavioral: Standard behavioral weight intervention, Intense behavioral weight interventionBipolar I Disorder, Schizophrenia203Sep 2009May 2013actual2014-12-17
AZNAstraZenecaAn Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar DisorderNCT01455961observationalDescription of detailed clinical treatment in terms of duration of treatment, doses, drug switches, and add-on therapy, in patients with BD and on treatment with quetiapine XR and/or quetiapine IR before, at and after the index date.CompletedBipolar Disorder16,000Nov 2011Apr 2012actual2014-08-21
AZNAstraZenecaPediatric Bipolar DepressionNCT00811473results2011-12-01Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)Phase 3CompletedDrug: Quetiapine XR, PlaceboBipolar Depression193Jan 2009Nov 2010actual2014-07-15
HLUN-B.COH. Lundbeck A/SEfficacy and Safety of Lu AA39959 in Patients With Bipolar DepressionNCT00771134Depressive symptoms as measured by the change from baseline in total MADRS scorePhase 2Terminatedsponsor's stated reason: Study was previously suspended and is now terminatedDrug: Lu AA39959, Placebo, QuetiapineBipolar Disorder105Dec 2008Jun 2009actual2014-05-28
AZNAstraZenecaA Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,StudyNCT01254721results2014-05-08The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29Phase 4Terminatedsponsor's stated reason: Difficulty of recruitment.Drug: Quetiapine fumarate, lithiumAcute Bipolar Mania131Dec 2010Oct 2012actual2014-05-08
AZNAstraZenecaGeneral Practice Research Database Seroquel XR Safety StudyNCT01447082observationalThe outcome of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine XR vs corresponding incidence rates in users of comparison drugsCompletedSchizophrenia, Major Depressive Disorder, Bipolar Disorder37,372Oct 2008Dec 2012actual2014-02-07
AZNAstraZenecaEMR Data to Assess Monitoring of Patients Treated With QuetiapineNCT01793324observationalDetermination whether physicians in the UK and Germany perform monitoring of patients treated with Seroquel® and Seroquel® XR including measurement of the following during patient encounters: weight at drug initiation and over the course of treatment.CompletedSchizophrenia, Bipolar Disorder, Major Depressive Disorder6,153Apr 2012Jun 2013actual2014-01-28
AZNAstraZenecaPhysician Survey on Monitoring of Patients Treated With QuetiapineNCT01795326observationalDetermination via survey whether physicians or someone in their practice perform monitoring of patients treated with Seroquel or Seroquel XR for metabolic issues related to treatment; refer their patients to another physician for monitoring.CompletedSchizophrenia, Bipolar Disorder, Major Depressive Disorder800Jun 2013Sep 2013actual2014-01-28
LLYEli Lilly and Company$1.15TA Study for Assessing Treatment of Patients Ages 10-17 With Bipolar DepressionNCT00844857results2013-02-18Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8Phase 4CompletedDrug: Olanzapine Fluoxetine Combination (OFC), PlaceboBipolar Depression291Apr 2009Feb 2012actual2013-02-18
PFEWyeth is now a wholly owned subsidiary of Pfizer$155.3BStudy Evaluating Bifeprunox in Bipolar DepressionNCT00134459The objective of this study is to investigate if 8 weeks of treatment with flexible doses of bifeprunox (20 to 40 mg/day) is superior to treatment with placebo in depressed outpatients with bipolar disorder.Phase 3CompletedDrug: Bifeprunox, PlaceboBipolar Disorder434Jun 2005May 2006actual2013-02-15
AZNAstraZenecaSeroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic PatientsNCT00139074The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)Phase 4Terminatedsponsor's stated reason: terminated due to very low recruitment rate (27 June 2006)Drug: Quetiapine fumarate, sodium valproateBipolar Disorder17Jul 2005Jun 2006actual2013-01-28
AZNAstraZenecaQuetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I DisorderNCT00227305results2012-10-05Incidence and Nature of Adverse Events (AEs)Phase 3CompletedDrug: quetiapine fumarateSchizophrenia, Bipolar I Disorder381Aug 2004Dec 2007actual2013-01-08
AZNAstraZenecaControlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar DepressionNCT00083954Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total scorePhase 3CompletedDrug: Quetiapine FumarateBipolar Disorder530Jun 20042013-01-04
AZNAstraZenecaQuetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I ManiaNCT00090311Compare efficacy of Quetiapine with placebo in the treatment of bipolar I mania as assessed by the YMRS total score, change from baseline to Day 21Phase 3CompletedDrug: quetiapine fumarateBipolar Disorder220Jul 20042013-01-04
AZNAstraZenecaEfficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar DisorderNCT00114686Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scalePhase 3CompletedDrug: Quetiapine fumarate, lithium, divalproexBipolar I Disorder, Alcohol Dependence350Jan 20062013-01-04
AZNAstraZenecaSeroquel in Bipolar Depression Versus SSRINCT00119652Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)Phase 3CompletedDrug: quetiapine fumarate (Seroquel), paroxetine · Behavioral: mood stabilizing activityBipolar Disorder, Bipolar Depression, Depression676May 20052013-01-04
AZNAstraZenecaSeroquel in Bipolar Depression Versus LithiumNCT00206141The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.Phase 3CompletedDrug: Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)Bipolar Disorder, Bipolar Depression, Depression672Aug 20052013-01-04
AZNAstraZenecaFunctional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-upNCT01255982observationalDifference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional changeCompletedBipolar Disorder, Bipolar Depression249Mar 2011Dec 2011actual2012-10-26
AZNAstraZenecaIBIS: Italian Burden of Illness on Schizophrenia & Bipolar DisorderNCT01392482observationalDescribe the pharmacoutilization of antipsychotics treatment (including typical and atypical) for patients affected by schizophrenia and bipolar disorder in order to evaluate the level of treatment variability for these patientsCompletedSchizophrenia, Bipolar Disorder751,725Jul 2011Sep 2012actual2012-09-17
AZNAstraZenecaEffectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.NCT00521365results2012-07-17Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)Phase 4CompletedDrug: Quetiapine 600mgBipolar Disorder, Bipolar Affective Psychosis, Mania, Manic Disorder, Manic State88May 2008Aug 2009actual2012-07-17
LLYEli Lilly and Company$1.15TA Study of LY2979165 in Healthy SubjectsNCT01383967Number of participants with clinically significant effectsPhase 1CompletedDrug: LY2979165, placeboBipolar Disorder102Jul 2011Jun 2012actual2012-06-14
AZNAstraZenecaStudy of the Clinical Management of Bipolar DiseaseNCT01062607observationalDemographic variablesCompletedBipolar Disorders2,965Apr 2010Jun 2011actual2012-05-23
AZNAstraZenecaQuetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on TherapyNCT00857584results2012-04-10The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total ScorePhase 3CompletedDrug: Extended release quetiapine (quetiapine XR), Sertraline, adequate mood stabilizerBipolar Disorder, Bipolar Depression27May 2009Feb 2011actual2012-04-18
AZNAstraZenecaStudy of the Broad Clinical Benefit for Seroquel XR With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current TherapyNCT01128114results2012-04-10The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)Phase 4Terminatedsponsor's stated reason: Poor recruitmentDrug: Quetiapine fumarate (Seroquel XR)Acute Bipolar Mania32Jun 2010Mar 2011actual2012-04-17
AZNAstraZenecaA Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.NCT01202604observationalThe proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed)CompletedBipolar Disorder294Sep 2010Dec 2011actual2011-12-20
AZNAstraZenecaPHARMO Institute Seroquel Safety StudyNCT01342120observationalThe outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugsCompletedSchizophrenia, Major Depressive Disorder, Bipolar Disorder, Generalized Anxiety Disorder18,325Sep 2010Nov 2010actual2011-09-02
AZNAstraZenecaSingle Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4451NCT01196676To assess the safety and tolerability of single ascending oral doses of AZD4451 by assessing AEs, vital signs, physical examinations, neurological examinations clinical laboratory parameters, Columbia Suicide Severity Rating Scale(CSSRS), EEGs and ECGsPhase 1CompletedDrug: AZD4451, PlaceboBipolar Disorder63Aug 2010Apr 2011actual2011-08-01
LLYEli Lilly and Company$1.15TSafety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, DepressedNCT00618748results2011-06-27Percentage of Participants With Adverse Events Leading to DiscontinuationPhase 3CompletedDrug: OlanzapineBipolar I Disorder101Feb 2008Sep 2010actual2011-07-27
AZNAstraZenecaThe Purpose of the Study is to Gain an In-depth Picture of the Patient Management and Prescription BehavioursNCT01377896observationalCompletedSchizophrenia, Bipolar Disorders, Major Depressive Disorders221Jul 2010Oct 2010actual2011-06-28
LLYEli Lilly and Company$1.15TA First Human Dose Study to Investigate Safety and Tolerability of LY2979165 in Healthy VolunteersNCT01248052Number of participants with clinically significant effectsPhase 1CompletedDrug: LY2979165, PlaceboBipolar Disorder25Nov 2010May 2011actual2011-06-27
LLYEli Lilly and Company$1.15TOlanzapine Treatment of Patients With Bipolar I DisorderNCT00510146results2011-05-26Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)Phase 3CompletedDrug: Olanzapine, PlaceboDepression, Bipolar514Aug 2007Mar 2010actual2011-05-26
AZNAstraZenecaStudy Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar DepressionNCT00926393results2011-03-31Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)Phase 4CompletedDrug: Quetiapine Immediate Release, Quetiapine Extended ReleaseBipolar Depression139Jun 2009Aug 2009actual2011-05-11
AZNAstraZenecaSafety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar DepressionNCT00060489Phase 3CompletedDrug: SEROQUEL (quetiapine fumarate) TabletsBipolar Disorder, Depression, BipolarSep 2002Sep 2003actual2011-01-26
SNYSanofiSafety Study of Sodium Divalproate in Bipolar Disorder in AdolescentsNCT00271258clinical examinationPhase 3CompletedDrug: SODIUM DIVALPROATEBipolar Disorder200Jan 20052011-01-11
LLYEli Lilly and Company$1.15TTrial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I DisorderNCT00129220results2010-02-15Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total ScorePhase 3CompletedDrug: olanzapine, haloperidol, placeboBipolar Disorder224Jul 2005Jan 2009actual2010-12-28
AZNAstraZenecaA NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II DisorderNCT00888264observationalDetails of any AAP prescribed 1 to 6 months prior to the first study visit:CompletedBipolar Disorders152May 2009Aug 2010actual2010-12-22
AZNAstraZenecaFAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute PsychosisNCT00486798Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1Phase 3Terminatedsponsor's stated reason: study was not ethically acceptable to continue and therefore it was finally stoppedDrug: Quetiapine · Procedure: Rating Scales, Self Assessment Form, Blood and urine samples, Sleeping patternPsychotic Disorders, Schizophrenia, Bipolar DisorderMay 2007Aug 2007actual2010-12-10
AZNAstraZenecaSpanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic TreatmentNCT00692133observationalTOOL questionnaireCompletedSchizophrenia, Bipolar Disorder250Mar 2008Aug 2008actual2010-12-10
AZNAstraZenecaEfficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder PatientsNCT00448578Effectiveness of quetiapine fumarate used as monotherapy in treatment of symptoms of acute mania in patients with bipolar disorder by evaluation of the change from baseline in YMRS total score at Day 28 using the last observation carried forward methodPhase 3CompletedDrug: Quetiapine Fumarate, LithiumMania, Bipolar Disorder150Aug 20052010-12-09

Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.

How Bipolar Disorder is matched — 11 exact registry spellings

A study is on this page when its ClinicalTrials.gov record names one of these conditions exactly (letter case aside). Nothing is matched by substring or stem, so a longer condition that merely contains one of these words is a different page. The list was curated by hand and last measured 2026-08-19; a spelling filed by only one study was not curated, so the counts here are a floor rather than the registry's own total for the disease.

  • Bipolar Disorder
  • Bipolar I Disorder
  • Bipolar Depression
  • Bipolar II Disorder
  • Bipolar 1 Disorder
  • Depression, Bipolar
  • Bipolar Disorders
  • Acute Bipolar Mania
  • Affective Psychosis, Bipolar
  • Bipolar Disorder I
  • Bipolar Disorder II

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