Clinical trials: Bipolar Disorder I
Schizophrenia, Bipolar I Disorder
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a)…
- Trial name
- NCT01206517
- Testing
- Asenapine 2.5 mg, Asenapine 5 mg, Asenapine 10 mg
- Volunteers
- 30 people
- Sponsor
- Organon and Co
Bipolar Disorder, Mania
Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder
This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum Disorder.
- Trial name
- NCT00181870
- Testing
- carbamazepine ER (Equetro)
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Massachusetts General Hospital
Bipolar Disorder, Bipolar I Disorder
Children's Bipolar Network Treatment Trial I
This is a naturalistic treatment and follow-up study of youth with bipolar spectrum disorders (BSDs) across four US sites of The Childhood Bipolar Network (CBN).
- Conditions
- Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder
- Trial name
- CBN (NCT05427123)
- Testing
- Medication or psychosocial treatment
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of California, Los Angeles
Bipolar Disorder
A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder
This primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with lithium or placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.
- Trial name
- NCT00037674
- Testing
- Topiramate
- Volunteers
- 434 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bipolar I Disorder
A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.
- Trial name
- NCT00195780
- Testing
- Divalproex Sodium (Depakote ER)
- Where
- 29 sites in United States
- Volunteers
- 227 people
- Sponsor
- Abbott
Bipolar Disorder
Open-Label Study of N-Acetylcysteine in Children and Adolescents 5-17 With Bipolar Spectrum Disorders
Children between the ages of 5-17 years old who have or display symptoms of emotional dysregulation (explosiveness, mood swings, irritability, and/or violent behavior) are invited to participate in a 12-week research study to…
- Trial name
- NCT02357290
- Testing
- Open-label Treatment with N-Acetylcysteine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital
Bipolar Depression
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as…
- Trial name
- NCT06372964
- Testing
- Lumateperone
- Where
- 68 sites in United States, Colombia and 2 more
- Volunteers
- 384 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Disorder
Safety And Tolerability Of Flexible Doses Of Oral 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 a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).
- Trial name
- NCT01124877
- Testing
- ziprasidone oral capsules
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Disorder, Mania
Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar Disorder
This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8 weeks.
- Trial name
- NCT00181779
- Testing
- aripiprazole (Abilify)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Massachusetts General Hospital
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 (BD), Bipolar Disorder I or II
FOCUS Bipolar: Families Opening Conversations for Understanding Signs
Bipolar disorder often runs in families, but early symptoms in youth can go unrecognized for years. This project evaluates a structured, family-centered approach to informed screening for youth ages 7-21 who have a biological…
- Conditions
- Bipolar Disorder (BD), Bipolar Disorder I or II, Bipolar Disorder Family Members, Screening Tool
- Trial name
- FOCUS Bipolar (NCT07622927)
- Testing
- Co-design Workshop (Observational Procedure), Alpha Testing (Observational Procedure), Beta Testing (Observational Procedure)
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Bipolar Disorders, Mood Disorders
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.
- Conditions
- Bipolar Disorders, Mood Disorders, Affective Disorders, Psychotic
- Trial name
- NCT00240721
- Testing
- topiramate
- Volunteers
- 363 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
Schizophreniform Disorder, Bipolar I Disorder
Prevention of Weight Gain in Early Psychoses
The purpose of this study is to determine whether individuals with psychotic spectrum disorders ( Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II),Major…
- Conditions
- Schizophreniform Disorder, Bipolar I Disorder, Bipolar II Disorder, Major Depressive Disorder
- Trial name
- NCT01075295
- Testing
- Behavioural Intervention for the Prevention of Weight Gain, TAU
- Where
- Canada
- Volunteers
- 70 people
- Sponsor
- Centre for Addiction and Mental Health
Schizophrenia, Bipolar Disorder
A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders
The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
- Conditions
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- Trial name
- NCT00650611
- Testing
- Ziprasidone
- Where
- 17 sites in United States
- Volunteers
- 63 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Schizophrenia, Schizophreniform Disorders
Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness
- Conditions
- Schizophrenia, Schizophreniform Disorders, Bipolar I Disorder
- Trial name
- NCT03187769
- Testing
- ALKS 3831, Olanzapine
- Where
- 57 sites in United States, Austria and 10 more
- Volunteers
- 426 people
- Sponsor
- Alkermes, Inc.
Gut Microbiome, Gastrointestinal Microbiome
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
- Conditions
- Gut Microbiome, Gastrointestinal Microbiome, Autism, Autism Spectrum Disorder
- Trial name
- NCT04031469
- Testing
- There is no intervention in this study
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- ProgenaBiome
First Episode Psychosis, Schizophrenia, Childhood
Early Psychosis Intervention - Spreading Evidence-based Treatment
Implementation of 'NAVIGATE' in Ontario aims to help youth and emerging adults suffering from a first episode of psychosis. Although Ontario already has early psychosis intervention programs, the team's recent work has identified…
- Conditions
- First Episode Psychosis, Schizophrenia, Childhood, Psychosis, Schizophrenia
- Trial name
- EPI-SET (NCT03919760)
- Testing
- NAVIGATE, Treatment as Usual
- Where
- 6 sites in Canada
- Volunteers
- 100 people
- Sponsor
- Centre for Addiction and Mental Health
Bipolar Disorder I
Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)
To investigate the safety for an observation period of 52 weeks with use of Abilify prolonged release aqueous suspension for intramuscular (IM) injection in patients with bipolar I disorder for prevention of recurrence/relapse of…
- Trial name
- NCT04812379
- Testing
- Abilify prolonged release aqueous suspension for IM injection (Aripiprazole)
- Where
- Japan
- Volunteers
- 535 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar Disorder
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
The study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with Bipolar I…
- Trial name
- NCT00723450
- Testing
- lamictal
- Where
- 46 sites in United States
- Volunteers
- 301 people
- Sponsor
- GlaxoSmithKline