Clinical trials: Bipolar I Disorder
Bipolar Disorder
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet…
- Trial name
- NCT00194116
- Testing
- Divalproex Sodium ER
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Bipolar I Disorder
An Observational Modified Prescription-event Monitoring Study of Asenapine (Sycrest)
This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk Management Plan required by the Committee…
- Trial name
- NCT01765127
- Where
- United Kingdom
- Volunteers
- 122 people
- Sponsor
- Professor Saad Shakir
Adolescent Schizophrenia, Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.
This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.
- Trial name
- ATTAIN 267 (NCT01122927)
- Testing
- Aripiprazole
- Where
- 101 sites in United States, Bulgaria and 11 more
- Volunteers
- 524 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Schizophrenia, Schizophreniform Disorder
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder
- Conditions
- Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
- Trial name
- NCT03201757
- Testing
- ALKS 3831
- Where
- 85 sites in United States, Austria and 11 more
- Volunteers
- 523 people
- Sponsor
- Alkermes, 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.
Obsessions, Suicide
Obsessions and Suicidality in Youth With Bipolar 1 Disorder
Obsessive-compulsive disorder (OCD) is a common co-morbidity with bipolar I disorder, a comorbidity that is known to increase suicide risk.
- Conditions
- Obsessions, Suicide, Bipolar I Disorder, Obsessive-Compulsive Disorder
- Trial name
- NCT05878808
- Testing
- Psychometric assessment
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Cairo University
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 Disorder, Pediatric
Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107)
Efficacy and safety of asenapine for the treatment of bipolar I disorder (manic or mixed episodes) will be evaluated in participants between 10 and 17 years old, who are either hospitalized or non-hospitalized.
- Trial name
- NCT01244815
- Testing
- asenapine, Rescue medication
- Volunteers
- 404 people
- Sponsor
- Organon and Co
Bipolar Disorder, Mania
Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder.
- Trial name
- NCT00181844
- Testing
- lamotrigine
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Massachusetts General Hospital
Schizophrenia, Bipolar I Disorder
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
- Trial name
- NCT05303064
- Testing
- OLZ/SAM, Olanzapine
- Where
- 47 sites in United States, Argentina and 3 more
- Volunteers
- 220 people
- Sponsor
- Alkermes, 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
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
Schizophrenia, Schizoaffective Disorder
Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
The overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic naive children and adolescents in order to inform…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychosis NOS
- Trial name
- NCT01731119
- Testing
- Latuda©
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of North Carolina, Chapel Hill
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.
Mania, Bipolar I
Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old
This study is an 8-week open-label trial testing Lurasidone (Latuda®) as a treatment for mania in children and adolescents with Bipolar I, Bipolar II, and Bipolar Spectrum disorders.
- Conditions
- Mania, Bipolar I, Bipolar II, Bipolar Spectrum Disorder
- Trial name
- NCT01932541
- Testing
- Latuda (Lurasidone)
- Where
- United States
- 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 I Depression
Lurasidone Pediatric Bipolar Study
A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression
- Trial name
- Illuminate (NCT02046369)
- Testing
- Lurasidone
- Where
- 66 sites in United States, Bulgaria and 9 more
- Volunteers
- 350 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar I Disorder, Manic or Mixed
Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents
To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective in the treatment of bipolar I disorder in children and adolescents.
- Trial name
- NCT00195767
- Testing
- divalproex sodium
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Abbott
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