Clinical trials: Bipolar Disorder I
Bipolar Disorder
Aripiprazole in Children and Adolescents With Bipolar I Disorder
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.
- Trial name
- NCT00110461
- Testing
- Aripiprazole
- Where
- 53 sites in United States
- Volunteers
- 296 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
- Trial name
- NCT00257166
- Testing
- Ziprasidone oral capsules
- Where
- 50 sites in United States
- Volunteers
- 238 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Disorder
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed.
- Trial name
- NCT00282464
- Testing
- Geodon (Ziprasidone)
- Where
- 43 sites in United States
- Volunteers
- 392 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar I Disorder, Schizophrenia
Study in Adolescents With Schizophrenia or Bipolar Disorder
Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years, with bipolar I disorder (manic or mixed episodes) or schizophrenia.
- Trial name
- NCT00982020
- Testing
- Olanzapine, Standard behavioral weight intervention, Intense behavioral weight intervention
- Where
- 14 sites in United States, Poland and 2 more
- Volunteers
- 203 people
- Sponsor
- Eli Lilly and Company
Bipolar I Disorder
A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.
- Trial name
- NCT00402324
- Testing
- olanzapine, divalproex
- Where
- United States
- Volunteers
- 202 people
- Sponsor
- Eli Lilly and Company
Bipolar 1 Disorder
Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.
- Trial name
- NCT01674010
- Testing
- ELND005, Lamotrigine, Valproic acid
- Where
- 82 sites in United States, Bulgaria and 7 more
- Volunteers
- 309 people
- Sponsor
- OPKO Health, Inc.
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 I Disorder
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.
- Trial name
- NCT00606281
- Testing
- Aripiprazole
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 258 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar I Disorder, Acute Mania
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder.
- Trial name
- NCT03287869
- Testing
- Brexpiprazole
- Where
- 73 sites in United States, Bulgaria and 4 more
- Volunteers
- 381 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Disorder, Bipolar II Disorder
Sensoril(Ashwaganhda)for Bipolar Disorder
The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance cognitive abilities (specifically measures of attention, executive function, working memory, and visuospatial ability) in persons with…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS
- Trial name
- NCT00761761
- Testing
- Sensoril
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Pittsburgh
Bipolar Disorder
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
- Trial name
- NCT00277212
- Testing
- Lamotrigine + Aripiprazole
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 1,169 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder, Anxiety Disorders
Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
The specific goal of this research study is to investigate the feasibility, acceptability, and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed specifically to target common core processes across…
- Trial name
- NCT01892306
- Testing
- UP CBT, Treatment as usual
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Massachusetts General Hospital
Bipolar I Disorder
Staccato Loxapine in Agitated Patients With Bipolar Disorder
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.
- Trial name
- NCT00721955
- Testing
- Inhaled loxapine 5 mg, Inhaled loxapine 10 mg
- Where
- 6 sites in United States
- Volunteers
- 314 people
- Sponsor
- Alexza Pharmaceuticals, Inc.
Bipolar Disorder
A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -
This study is planned to assess the long-term safety of lamotrigine in Japanese patients with bipolar I disorder who will continue into the 52-week extension upon completion of a double-blind comparative study (Study No.…
- Trial name
- NCT00566020
- Testing
- BW430C (lamotrigine)
- Where
- 52 sites in Japan
- Volunteers
- 92 people
- Sponsor
- GlaxoSmithKline
Bipolar Disorder I, Bipolar Disorder II
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.
- Conditions
- Bipolar Disorder I, Bipolar Disorder II, Major Depressive Episode
- Trial name
- NCT03692910
- Testing
- SAGE-217
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Biogen
Bipolar Disorder
Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)
- Trial name
- NCT00265330
- Testing
- Ziprasidone oral capsules
- Where
- 41 sites in United States
- Volunteers
- 169 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris 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 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
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
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
- NCT00868699
- Testing
- lurasidone
- Where
- 55 sites in United States, Czechia and 6 more
- Volunteers
- 505 people
- Sponsor
- Sumitomo Pharma America, 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.