Clinical trials: Bipolar Depression
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 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.
Depressive Episodes, Bipolar I Depression
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).
This is 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).
- Trial name
- NCT05227209
- Testing
- SEP-4199 CR
- Where
- 69 sites in United States, Bulgaria and 1 more
- Volunteers
- 64 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar Depression
Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar…
- Trial name
- NCT02362412
- Testing
- FK949E
- Where
- 7 sites in Japan
- Volunteers
- 22 people
- Sponsor
- Astellas Pharma Inc
Depressive Episodes, Bipolar I Depression
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive…
- Trial name
- NCT05169710
- Testing
- SEP-4199 CR 200 mg, SEP-4199 CR 400 mg
- Where
- 89 sites in United States, Bulgaria and 4 more
- Volunteers
- 83 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar I Disorder, Mania
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e.
- Conditions
- Bipolar I Disorder, Mania, Depression
- Trial name
- NCT03573297
- Testing
- Cariprazine
- Where
- 108 sites in United States, Bulgaria and 9 more
- Volunteers
- 901 people
- Sponsor
- AbbVie
Depressive Episode, Bipolar 1 Depression
A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression
A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression
- Trial name
- NCT03543410
- Testing
- SEP-4199 200 mg, SEP-4199 400 mg
- Where
- 87 sites in United States, Bulgaria and 6 more
- Volunteers
- 344 people
- Sponsor
- Sumitomo Pharma America, Inc.
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 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
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
- Trial name
- NCT01986101
- Testing
- SM-13496
- Where
- 8 sites in Japan, Lithuania and 6 more
- Volunteers
- 525 people
- Sponsor
- Sumitomo Pharma Co., Ltd.
Bipolar Depression, Suicidal Ideas
Sequential Therapy for the Treatment of Severe Bipolar Depression.
NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or…
- Conditions
- Bipolar Depression, Suicidal Ideas, Suicidal Ideation, Suicide, Attempted
- Trial name
- STABIL-B (NCT02974010)
- Testing
- NRX-101 Oral Capsule, Lurasidone Oral Capsule, Ketamine Intravenous Infusion
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- NeuroRx, Inc.
Bipolar Disorder, Depression, Bipolar
Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression.
- Trial name
- NCT00483548
- Testing
- Ziprasidone
- Where
- 70 sites in United States, Australia and 1 more
- Volunteers
- 298 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Schizophrenia, Autism
Pediatric Open-Label Extension Study
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have…
- Conditions
- Schizophrenia, Autism, Bipolar Depression
- Trial name
- NCT01914393
- Testing
- Lurasidone 20, 40, 60, 80 mg, flexibly dosed
- Where
- 88 sites in United States, Bulgaria and 13 more
- Volunteers
- 702 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar Disorder, Depression
Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I…
- Trial name
- NCT02670538
- Testing
- Cariprazine
- Where
- 89 sites in United States, Bulgaria and 6 more
- Volunteers
- 493 people
- Sponsor
- Forest Laboratories
Bipolar Disorder, Depression
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder.
- Trial name
- NCT02670551
- Testing
- Cariprazine
- Where
- 74 sites in United States, Bulgaria and 4 more
- Volunteers
- 488 people
- Sponsor
- Forest Laboratories
Bipolar Depression
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
- Trial name
- NCT00852202
- Testing
- cariprazine
- Where
- 26 sites in United States
- Volunteers
- 234 people
- Sponsor
- Forest Laboratories
Depression, Bipolar
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.
- Trial name
- NCT01396447
- Testing
- Cariprazine
- Where
- 88 sites in United States, Bulgaria and 4 more
- Volunteers
- 584 people
- Sponsor
- Forest Laboratories
Bipolar I Depression
Lurasidone Pediatric Bipolar Study
A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression
- Trial name
- Illuminate (NCT02046369)
- Testing
- Lurasidone
- Where
- 66 sites in United States, Bulgaria and 9 more
- Volunteers
- 350 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar Depression
Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with…
- Trial name
- NCT01256177
- Testing
- Quetiapine Fumarate (SEROQUEL) Extended Release
- Where
- 12 sites in China
- Volunteers
- 361 people
- Sponsor
- AstraZeneca
Bipolar Depression
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
- Trial name
- NCT00868959
- Testing
- lurasidone
- Where
- 151 sites in United States, Canada and 13 more
- Volunteers
- 817 people
- Sponsor
- Sumitomo Pharma America, Inc.