Clinical trials: Bipolar I Depression
Bipolar I Disorder
Study to Assess Accuracy of Rapid Mood Screener in Adult Participants With Unipolar Major Depressive Disorder or Bipolar 1 Disorder in Real World Setting
Bipolar I Disorder (BP1)is a severe chronic mood disorder characterized by manic and depression. BP1 has high probability of being misunderstood as unipolar major depressive disorder (MDD).
- Trial name
- NCT05956483
- Where
- 9 sites in United States
- Volunteers
- 423 people
- Sponsor
- AbbVie
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
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.
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
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.
Anxiety, Depression
Ginger.io Behavioral Health Study
This Study will evaluate the impact of a smartphone-based platform on a range of outcomes for medically-underserved patients with mood disorders (e.g.
- Conditions
- Anxiety, Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- NCT02491307
- Testing
- Ginger.io Smartphone Application
- Where
- 4 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Community Health Center, 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 I Disorder
Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed
To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.
- Trial name
- NCT00618748
- Testing
- Olanzapine
- Where
- 10 sites in Japan
- Volunteers
- 101 people
- Sponsor
- Eli Lilly and Company
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
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.
- Trial name
- NCT00868452
- Testing
- lurasidone + (lithium or divalproex)
- Where
- 71 sites in United States, Czechia and 8 more
- Volunteers
- 348 people
- Sponsor
- Sumitomo Pharma America, Inc.
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
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.
- Trial name
- NCT00094432
- Testing
- Aripiprazole
- Where
- 40 sites in United States
- Volunteers
- 650 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Depression
A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
The study evaluates the efficacy and safety of lurasidone compared with placebo in treating Bipolar I Depression.
- Trial name
- NCT04383691
- Testing
- Lurasidone HCl
- Where
- 26 sites in China
- Volunteers
- 124 people
- Sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
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 to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder
The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who…
- Trial name
- NCT00490971
- Testing
- Olanzapine, Paliperidone ER
- Where
- 78 sites in United States, Bulgaria and 14 more
- Volunteers
- 768 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bipolar Depression
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
The main goal of this study is to help answer the following research question(s) and not to treat the child's illness. Can this study drug make children with bipolar depression feel better? Does this study drug work better than a…
- Trial name
- NCT00844857
- Testing
- Olanzapine Fluoxetine Combination (OFC)
- Where
- 7 sites in United States, Russia
- Volunteers
- 291 people
- Sponsor
- Eli Lilly and Company
Bipolar Depression
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective…
- Trial name
- PREVAIL3 (NCT01284517)
- Testing
- Lurasidone
- Where
- 75 sites in United States, Canada and 8 more
- Volunteers
- 356 people
- Sponsor
- Sumitomo Pharma America, Inc.
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
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.