Clinical trials: Bipolar I Disorder
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 Disorder, Bipolar Depression
Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression
This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases.
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- NCT03603561
- Testing
- cTBS
- Where
- 2 sites in Belgium
- Volunteers
- 40 people
- Sponsor
- Universiteit Antwerpen
Bipolar Disorder
Examination of Tamoxifen in Acute Mania in Patients With Bipolar I Disorder
The purpose of this study is to examine how the drug tamoxifen affects the brain in patients with bipolar I disorder. Bipolar Disorder (BD) is a severe, chronic, and often life-threatening illness for which safe and effective…
- Trial name
- NCT00026585
- Testing
- Tamoxifen
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Institute of Mental Health (NIMH)
Bipolar I Disorder
Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo).
- Trial name
- Illuminate1 (NCT07494305)
- Testing
- LB-102
- Where
- 26 sites in United States
- Volunteers
- 320 people
- Sponsor
- LB Pharmaceuticals Inc.
Bipolar I Disorder
Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)
Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment.
- Trial name
- NCT01395992
- Testing
- asenapine
- Where
- United States
- Volunteers
- 165 people
- Sponsor
- Forest Laboratories
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
Lurasidone and Cognition in Bipolar I Disorder
This is a 6 week, randomized, open-label, parallel group study in patients with Bipolar-I disorder (manic depression), who are in remission from an episode.
- Trial name
- NCT02147379
- Testing
- Lurasidone
- Where
- Canada
- Volunteers
- 53 people
- Sponsor
- University of British Columbia
Bipolar Disorder, Mood Disorders
A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder
The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute…
- Trial name
- NCT00309699
- Testing
- Quetiapine, Paliperidone ER
- Where
- 47 sites in United States, Greece and 6 more
- Volunteers
- 493 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatment Resistant Depression
Effect of Lithium Versus Placebo in Adults With Treatment-Resistant Depression Who Are Receiving Ketamine
The purpose of this research study is to compare the antidepressant effect of lithium versus placebo in adults receiving ketamine.
- Trial name
- NCT03290963
- Testing
- Lithium, Ketamine
- Where
- United States
- Sponsor
- William V. Bobo, M.D.
Bipolar Disorder
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
The purpose of this study is to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
- Trial name
- NCT02075047
- Testing
- ziprasidone oral capsules
- Where
- 50 sites in United States, Ukraine
- Volunteers
- 171 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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, Bipolar I Disorder
Using Neuroplasticity-Based Computerized Training to Improve Emotion Regulation in Bipolar Disorder (BRAINS)
The goal of this study is to evaluate the feasibility and potential benefit of a behavioral intervention designed to improve emotion regulation in individuals with bipolar disorder.
- Conditions
- Bipolar Disorder, Bipolar I Disorder, Bipolar Affective Disorder, Bipolar Disorder I
- Trial name
- BRAINS (NCT05683431)
- Testing
- Cognitive Control of Emotion (CCE) Training
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Depression
A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major…
- Trial name
- NCT01072929
- Testing
- Armodafinil
- Where
- 40 sites in United States
- Volunteers
- 433 people
- Sponsor
- Cephalon
Bipolar Disorder
Lamotrigine Phase III Study in Bipolar I Disorder
This registration study in China is a multi-centre, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of lamotrigine in the prevention of recurrence/relapse of mood episodes in subjects with…
- Trial name
- NCT01602510
- Testing
- Lamotrigine
- Where
- 21 sites in China
- Volunteers
- 265 people
- Sponsor
- GlaxoSmithKline
Depression
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major…
- Trial name
- NCT01072630
- Testing
- Armodafinil
- Where
- 92 sites in United States, Argentina and 8 more
- Volunteers
- 492 people
- Sponsor
- Cephalon
Bipolar Depression
Brexpiprazole Treatment for Bipolar I Depression
Bipolar disorder (BD) is a frequent and lifelong recurrent mood disorder with treatment-resistant depressive episodes. Importantly, depressive symptoms and cognitive decline are major determinants of functionality and quality of…
- Trial name
- NCT04569448
- Testing
- Brexpiprazole
- Where
- 3 sites in Canada
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Douglas Mental Health University Institute
ADHD, Autism
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders.
- Conditions
- ADHD, Autism, Bipolar I Disorder, Conduct Disorder
- Trial name
- NCT03292848
- Testing
- Brexpiprazole
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Depression
Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression
The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.
- Trial name
- NCT00322764
- Testing
- Uridine
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Repligen Corporation
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 Affective Disorder
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving…
- Trial name
- NCT07412132
- Testing
- Lacosamide
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- University of Sao Paulo