| Bipolar Disorder |
2018-003313-17: Efficacy of vitamin D supplementation in patients with depressive disorder or bipolar disorder: randomized controlled clinical trial Efficacia della supplementazione con vitamina d in pazienti con disturbo depressivo o disturbo bipolare: studio clinico controllato randomizzato |
|
|
| Not yet recruiting | 3 | 150 | Europe | DIBASE, [DIBASE], Oral drops, solution, DIBASE - "50.000 U.I./2,5 ML SOLUZIONE ORALE" 1 CONTENITORE MONODOSE DA 2,5 ML | AZIENDA OSPEDALIERA UNIVERSITARIA SENESE, Abiogen | patients with major depressive disorder or bipolar disorder pazienti affetti da disturbo depressivo maggiore o disturbo bipolare, patients with major depressive disorder or bipolar disorder pazienti affetti da disturbo depressivo maggiore o disturbo bipolare, Psychiatry and Psychology [F] - Behaviours [F01] | | | | |
2018-002749-12: Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression |
|
|
| Not yet recruiting | 3 | 514 | Europe | ITI-007, Capsule | Intra-Cellular Therapies, Inc. (ITI), Intra-Cellular Therapies, Inc. (ITI) | Major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression), Bipolar Depression, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
SevereBD, NCT03396601: NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression |
|
|
| Active, not recruiting | 3 | 150 | US | Ketamine Hydrochloride, Placebo | NeuroRx, Inc., Target Health Inc. | Bipolar Depression, Suicidal Ideation | 12/24 | 12/24 | | |
NCT04819776: Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder |
|
|
| Completed | 3 | 417 | Europe, US | Iloperidone, FANAPT®, VYV-683, Iloperidone Placebo | Vanda Pharmaceuticals | Bipolar I Disorder | 09/22 | 08/23 | | |
NCT04285515 / 2019-004440-29: Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder |
|
|
| Completed | 3 | 488 | Europe, US, RoW | Lumateperone, Placebos | Intra-Cellular Therapies, Inc. | Bipolar Depression, Major Depressive Disorder | 11/22 | 11/22 | | |
SBD-ASIB, NCT03396068: NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation |
|
|
| Active, not recruiting | 3 | 72 | US | NRX-101, Cyclurad, Lurasidone HCl | NeuroRx, Inc., Target Health Inc. | Bipolar Depression, Suicidal Ideation | 12/24 | 12/24 | | |
|
NCT04315792: Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients |
|
|
| Recruiting | 3 | 124 | US | Endoxifen, Placebo oral tablet | Jina Pharmaceuticals Inc., Novum Pharmaceutical Research Services, Lambda Therapeutic Research Ltd., Intas Pharmaceuticals, Ltd. | Bipolar I Disorder | 07/23 | 05/24 | | |
2020-000405-83: A clinical study to evaluate iloperidone in the treatment of patients with acute manic episodes associated with Bipolar I Disorder Badanie kliniczne oceniające stosowanie iloperidonu w leczeniu pacjentów z ostrymi epizodami manii związanymi z chorobą dwubiegunową typu I |
|
|
| Not yet recruiting | 3 | 400 | Europe, RoW | Iloperidone, VYV-683, Capsule, Tablet | Vanda Pharmaceuticals Inc., Vanda Pharmaceuticals Inc. | Acute manic episodes associated with Bipolar I Disorder Ostre epizody manii związane z chorobą dwubiegunową typu I, Bipolar I Disorder Choroba dwubiegunowa typu I, Psychiatry and Psychology [F] - Mental Disorders [F03] | | | | |
| Completed | 3 | 524 | Europe, US, RoW | ALKS 3831 | Alkermes, Inc. | Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder | 09/23 | 09/23 | | |
NCT06229210: Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia or Bipolar Disorder |
|
|
| Recruiting | 3 | 500 | US | Lumateperone | Intra-Cellular Therapies, Inc. | Schizophrenia, Bipolar Disorder | 12/27 | 12/27 | | |
NCT06372964: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients |
|
|
| Recruiting | 3 | 384 | US | Lumateperone, Placebo | Intra-Cellular Therapies, Inc. | Bipolar Depression | 04/27 | 05/27 | | |
NCT05803642: A Study of Olanzapine in Patients With Acute Agitation |
|
|
| Not yet recruiting | 3 | 318 | NA | Olanzapine, Haloperidol | Qilu Pharmaceutical Co., Ltd. | Acute Agitation | 05/24 | 07/24 | | |
NCT06462586: Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania |
|
|
| Recruiting | 3 | 350 | US | Lumateperone, Placebo | Intra-Cellular Therapies, Inc. | Bipolar Disorder, Manic | 03/26 | 04/26 | | |
NCT06462612: Study of Lumateperone in the Treatment of Patients With Bipolar Mania |
|
|
| Not yet recruiting | 3 | 350 | US | Lumateperone, Placebo | Intra-Cellular Therapies, Inc. | Bipolar Disorder, Manic | 05/26 | 06/26 | | |
APOLLO, NCT03423680: A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression |
|
|
| Recruiting | 3 | 390 | RoW | Abilify 2, 5, 10, 15mg (Tablet), Placebo of Abilify 2, 5, 10, 15mg (Tablet) | Korea Otsuka Pharmaceutical Co., Ltd. | Depression, Bipolar | 10/24 | 11/24 | | |
NCT04777357: A 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. |
|
|
| Recruiting | 3 | 380 | US, RoW | Cariprazine, Vraylar, Placebo | AbbVie | Depression, Bipolar I Disorder | 03/27 | 03/27 | | |
NCT05658510: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) |
|
|
| Active, not recruiting | 3 | 450 | US | BXCL501, Dexmedetomidine, Matching Placebo, Placebo | BioXcel Therapeutics Inc, Worldwide Clinical Trials | Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders | 03/25 | 03/25 | | |
NCT05169710 / 2021-002126-24: A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder. |
|
|
| Terminated | 3 | 83 | Europe, Canada, Japan, US | SEP-4199 CR 200 mg, SEP-4199 CR 400 mg, Placebo | Sumitomo Pharma America, Inc., Sunovion Pharmaceuticals Inc. | Depressive Episodes, Bipolar I Depression | 10/23 | 10/23 | | |
NCT04578756: Open-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 Disorder |
|
|
| Recruiting | 3 | 280 | US | Cariprazine Flexible Dose | AbbVie | Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD) | 09/25 | 09/25 | | |
NCT05303064: Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder |
|
|
| Recruiting | 3 | 220 | US, RoW | OLZ/SAM, ALKS 3831, LYBALVI, Olanzapine | Alkermes, Inc. | Schizophrenia, Bipolar I Disorder | 09/26 | 09/26 | | |
NCT04987229: Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects |
|
|
| Enrolling by invitation | 3 | 236 | US, RoW | OLZ/SAM, ALKS 3831 | Alkermes, Inc. | Bipolar I Disorder, Schizophrenia | 09/27 | 09/27 | | |
NCT05227209 / 2021-002108-11: A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression). |
|
|
| Terminated | 3 | 64 | Europe, Japan, US | SEP-4199 CR | Sumitomo Pharma America, Inc., Sunovian Pharmaceuticals Inc. | Depressive Episodes, Bipolar I Depression | 11/23 | 11/23 | | |
| Completed | 2/3 | 74 | US | NRX-101, Lurasidone HCl, Latuda | NeuroRx, Inc., Prevail Infoworks, Inc | Bipolar Depression, Suicidal Ideation and Behavior | 02/24 | 03/24 | | |
| Recruiting | 2/3 | 256 | US | BHV-7000, Placebo | Biohaven Therapeutics Ltd. | Bipolar Disorder | 03/25 | 04/25 | | |
