Clinical trials: Bipolar 1 Disorder
Bipolar Disorder
Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
The purpose of this study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of mania in bipolar disorder in adolescents.
- Trial name
- NCT00050206
- Testing
- Olanzapine
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Eli Lilly and Company
Depression, Bipolar I Disorder
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States.
- Trial name
- 3112 Ped BPD (NCT04777357)
- Testing
- Cariprazine
- Where
- 81 sites in United States, Puerto Rico and 1 more
- Volunteers
- 380 people
- Sponsor
- AbbVie
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
Major Depressive Disorder, Unipolar Depression
RTMS Feasibility Study on Adolescent Depression Stimulation
This is an open-label study, in which all participants receives an active treatment with repetitive transcranial magnetic stimulation (rTMS) according to clinical protocol.
- Conditions
- Major Depressive Disorder, Unipolar Depression, Bipolar Depression
- Trial name
- NCT06126198
- Testing
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- Uppsala University
Schizophrenia, Bipolar I Disorder
Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.
- Trial name
- ANCHOR 150 (NCT00227305)
- Testing
- quetiapine fumarate
- Where
- 48 sites in United States, India and 7 more
- Volunteers
- 381 people
- Sponsor
- AstraZeneca
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.
Bipolar Disorder, Bipolar I Disorder
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Bipolar Disorder
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
- Conditions
- Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Bipolar Type I Disorder
- Trial name
- NCT04211428
- Testing
- No intervention
- Where
- United States
- Sponsor
- ProgenaBiome
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.
Bipolar Disorder
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and…
- Trial name
- NCT00067262
- Testing
- Divalproex Sodium Extended-Release Tablets
- Where
- 16 sites in United States
- Volunteers
- 150 people
- Sponsor
- Abbott
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
DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder
A phase 4 unequal randomization, double blind study to evaluate the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an Open label and long term maintenance treatment in children…
- Trial name
- NCT02623504
- Testing
- Carbamazepine
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Validus Pharmaceuticals
Schizophrenia, Autism
Lurasidone Pediatric Pharmacokinetics Study
This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric…
- Trial name
- NCT01620060
- Testing
- Lurasidone
- Where
- 10 sites in United States
- Volunteers
- 105 people
- Sponsor
- Sumitomo Pharma America, Inc.
Schizophrenia, Bipolar Disorder
Olanzapine Treated Adolescents With Schizophrenia or Bipolar I Disorder
The purpose of this study is to characterize olanzapine pharmacokinetics: the inter- and intra- subject variabilities of olanzapine pharmacokinetics; and the potential influence of patient factors such as age, weight, gender…
- Trial name
- NCT00113594
- Testing
- Olanzapine
- Where
- 17 sites in United States, Puerto Rico and 1 more
- Volunteers
- 100 people
- Sponsor
- Eli Lilly and Company
Bipolar Disorder
Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
A clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.
- Trial name
- NCT00076115
- Testing
- Risperidone
- Volunteers
- 13 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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