Clinical trials: Bipolar 1 Disorder
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.
Bipolar Disorder
A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Adult Participants With Bipolar Disorder
This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in adult participants with bipolar disorder.
- Trial name
- NCT07071532
- Testing
- ABBV-932, Itraconazole
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- AbbVie
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
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 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 I Disorder
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.
Patients with bipolar I disorder (BD) experience depression 3 times more frequently than mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of patients.
- Trial name
- NCT00958633
- Testing
- Escitalopram, Bupropion XL
- Where
- Canada
- Volunteers
- 237 people
- Sponsor
- University of British Columbia
Bipolar I Disorder
The Young Adult and Pediatric Bipolar Study
To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.
- Trial name
- NCT00350857
- Testing
- Extended-Release Carbamazepine
- Where
- 26 sites in United States
- Volunteers
- 161 people
- Sponsor
- Validus Pharmaceuticals
Major Depressive Disorder, Bipolar I and Bipolar II
Bipolar Proteomic Assay Validation Study
The purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive episode.
- Trial name
- NCT02746367
- Testing
- Diagnostic test (LDT)
- Where
- 5 sites in United States
- Volunteers
- 261 people
- Sponsor
- Myriad Genetic Laboratories, 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, Bipolar II Disorder
Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizo Affective Disorder, Obesity
- Trial name
- OBOE-Mayo (NCT07213466)
- Testing
- Group Therapy Program, semaglutide, Phentermine-Topiramate
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mayo Clinic
Bipolar I Disorder
Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients
This will be a randomized, double-blind, placebo-controlled trial to assess the time to recurrence of any mood episode in subjects with bipolar I disorder who have maintained stability on aripiprazole IM depot for at least 8…
- Trial name
- NCT01567527
- Testing
- Intramuscular (IM) Depot Aripiprazole
- Where
- 76 sites in United States, Canada and 5 more
- Volunteers
- 731 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder, Bipolar Depression
Maintenance Ketamine Infusions for Treatment-Resistant Bipolar Depression
Growing evidence has supported rapid and robust antidepressant effects with subanesthetic doses of intravenous (IV) ketamine for treatment resistant depression (TRD).
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- KET-BD-Sustain (NCT05339074)
- Testing
- Ketamine Hydrochloride
- Where
- 3 sites in Canada
- Volunteers
- 41 people
- Sponsor
- Joshua Rosenblat
Bipolar 1 Disorder
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder
This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania…
- Trial name
- NCT07046494
- Testing
- RAP-219
- Where
- 20 sites in United States
- Volunteers
- 253 people
- Sponsor
- Rapport Therapeutics Inc.
Bipolar I Disorder
Optimizing Response to Li Treatment Through Personalized Evaluation of Individuals With Bipolar I Disorder: The R-LiNK Initiative
Bipolar disorder (BD), especially BD type I, is a highly prevalent mental disorder and a is a highly prevalent mental disorder and an important factor for suicide.
- Trial name
- R-LiNK (NCT04209140)
- Testing
- lithium treatment
- Where
- France
- Volunteers
- 320 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris