Clinical trials: Bipolar Disorder I or II
Bipolar Depression, Bipolar I Disorder
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar…
- Conditions
- Bipolar Depression, Bipolar I Disorder, Bipolar Disorder, Bipolar II Disorder
- Trial name
- NCT07217860
- Testing
- Azetukalner
- Where
- 20 sites in United States
- Volunteers
- 400 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Schizophrenia, Major Depressive Disorder (MDD)
A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive…
- Conditions
- Schizophrenia, Major Depressive Disorder (MDD), Bipolar Disorder
- Trial name
- NCT07549581
- Testing
- SEP-380135
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.
The primary objective of the study is to evaluate the efficacy of administered maintenance treatments in bipolar disorder I and II, defined as the percentage of patients who experience a relapse episode during the first 9 months…
- Trial name
- NCT01202604
- Where
- 33 sites in Greece
- Volunteers
- 294 people
- Sponsor
- AstraZeneca
Depression, Bipolar
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or…
- Trial name
- APOLLO (NCT03423680)
- Testing
- Abilify 2, 5, 10, 15mg (Tablet)
- Where
- South Korea
- Volunteers
- 390 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Bipolar Depression
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B.
- Trial name
- NCT02600494
- Testing
- ITI-007 (Lumateperone)
- Where
- 55 sites in United States
- Volunteers
- 554 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar I Disorder, Bipolar II Disorder
Study of Oral ABBV-932 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Bipolar I or II Disorder
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. This study will assess how safe and effective ABBV-932 is in treating participants with bipolar I or II…
- Trial name
- CANTO (NCT06605599)
- Testing
- ABBV-932
- Where
- 40 sites in United States, Japan and 1 more
- Volunteers
- 161 people
- Sponsor
- AbbVie
Depression in Patients With Bipolar Disorder
Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.
- Trial name
- NCT00622245
- Testing
- Lu AA34893, Quetiapine fumarate
- Where
- 50 sites in Australia, Austria and 16 more
- Volunteers
- 166 people
- Sponsor
- H. Lundbeck A/S
Bipolar I Disorder, Bipolar II Disorder
A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States.
- Trial name
- NCT06696755
- Testing
- Icalcaprant
- Where
- 33 sites in United States
- Volunteers
- 195 people
- Sponsor
- AbbVie
Bipolar Depression
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar…
- Trial name
- NCT02600507
- Testing
- Lumateperone (ITI-007)
- Where
- 71 sites in United States, Bulgaria and 3 more
- Volunteers
- 529 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar I or II Disorder
Study to Assess the Adverse Events of Oral ABBV-932 in Adult Participants With Depressive Episodes Associated With Bipolar I or II Disorder
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the United States. The purpose of this study is to assess how safe and effective ABBV-932 is in treating participants with…
- Trial name
- NCT07220460
- Testing
- ABBV-932
- Where
- 49 sites in United States, Puerto Rico
- Volunteers
- 84 people
- Sponsor
- AbbVie
Bipolar Disorder
The 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.
Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with…
- Trial name
- NCT00154323
- Testing
- Oxcarbazepine
- Volunteers
- 55 people
- Sponsor
- Novartis
Bipolar Disorders
A NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder
The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II Disorder, in the course of a major depressive episode.
- Trial name
- HARMONY (NCT00888264)
- Where
- 45 sites in Belgium
- Volunteers
- 152 people
- Sponsor
- AstraZeneca
Bipolar Disorder
Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression
This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.
- Trial name
- NCT00771134
- Testing
- Lu AA39959, Quetiapine
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- H. Lundbeck A/S
Bipolar Disorder I or II With a Major Depressive Episode
ALTO-100 in Bipolar Disorder With Depression (BD-D)
The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used…
- Trial name
- NCT06656416
- Testing
- ALTO-100
- Where
- 68 sites in United States, United Kingdom
- Volunteers
- 200 people
- Sponsor
- Alto Neuroscience
Bipolar Depression
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as…
- Trial name
- NCT06372964
- Testing
- Lumateperone
- Where
- 68 sites in United States, Colombia and 2 more
- Volunteers
- 384 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Disorder
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling.
- Trial name
- NCT00254774
- Testing
- quetiapine fumarate or valproate
- Where
- 3 sites in Germany
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Bipolar Depression
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major…
- Trial name
- NCT03249376
- Testing
- Lumateperone
- Where
- 47 sites in United States, Bulgaria and 4 more
- Volunteers
- 381 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Depression, Major Depressive Disorder
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or…
- Trial name
- NCT04285515
- Testing
- Lumateperone
- Where
- 42 sites in United States, Bulgaria and 3 more
- Volunteers
- 488 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Disorder, Bipolar Depression
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a…
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- X-CEED (NCT07172516)
- Testing
- Azetukalner
- Where
- 44 sites in United States, Bulgaria and 2 more
- Volunteers
- 400 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Bipolar Disorder I or II
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.
- Trial name
- NCT00259272
- Testing
- olanzapine
- Where
- 16 sites in France
- Volunteers
- 141 people
- Sponsor
- Eli Lilly and Company