Clinical trials: Pediatric Bipolar Disorder
Bipolar I Disorder Without Psychotic Symptoms
Lithium for the Treatment of Pediatric Mania
This clinical trial is being performed under the Best Pharmaceuticals for Children Act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs.
- Trial name
- NCT00442039
- Testing
- Lithium Carbonate
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
Pediatric Bipolar Disorder, Pediatric OCD
Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
This will be a 12-week open-label pilot treatment study for children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) and obsessive-compulsive disorder (OCD) who are adequately mood stabilized on a…
- Trial name
- NCT00592852
- Testing
- fluoxetine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Massachusetts General Hospital
Bipolar 1 Disorder, Schizophrenia Disorder
An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)
To provide continued access to OLZ/SAM for pediatric participants with schizophrenia or bipolar I disorder who have completed participation in the ALKS 3831-A313 long-term safety extension study.
- Trial name
- NCT07744113
- Testing
- OLZ/SAM
- Where
- United States
- Sponsor
- Alkermes, Inc.
Bipolar Disorder
Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)
This study will investigate the safety and tolerability of a flexible dosing regimen of asenapine for the long-term treatment of manic or mixed episodes associated with bipolar disorder I in children and adolescents who completed…
- Trial name
- ADDRESS-98 (NCT01349907)
- Testing
- Asenapine, Rescue medication
- Volunteers
- 322 people
- Sponsor
- Organon and Co
Pediatric Bipolar Disorder
Screening Protocol for Children and Adolescents With Bipolar and Bipolar Spectrum Disorder
The objective of this protocol is to establish a comprehensive screening process for the evaluation of eligibility for entry in a clinical trial program for children and adolescents with bipolar disorder.
- Trial name
- NCT00592267
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Massachusetts General Hospital
Bipolar Disorder
Lamotrigine Monotherapy in Pediatric Bipolar Disorder
There are two purposes for this project. Study 1 is intended to study the safety and efficacy of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder (Phases: mixed, manic, hypomanic, or depressed…
- Trial name
- NCT00176228
- Testing
- Lamotrigine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Illinois Chicago
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 I Disorder
Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder
To evaluate the safety, tolerability, and pharmacokinetics of olanzapine and samidorphan in clinically stable pediatric subjects (10 to 12 years old) with Bipolar I disorder following oral administration of multiple ascending…
- Trial name
- NCT04987658
- Testing
- OLZ/SAM
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Alkermes, Inc.
Post-Acute COVID-19 Syndrome, ME/CFS
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related…
- Conditions
- Post-Acute COVID-19 Syndrome, ME/CFS, Rheumatic Arthritis, Juvenile Rheumatoid Arthritis (JRA)
- Trial name
- NCT04806620
- Where
- United States
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Brain Inflammation Collaborative
Bipolar Disorder
Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)
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 l Disorder (Manic or Mixed).
- Trial name
- NCT01117220
- Testing
- Ziprasidone Oral Capsules
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Disorder, Pediatric Bipolar Disorder
Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study
The main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents.
- Conditions
- Bipolar Disorder, Pediatric Bipolar Disorder, Childhood-onset Bipolar Disorder
- Trial name
- COGFLEX (NCT01954680)
- Testing
- COGFLEX-skill building levels, COGFLEX-control condition
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Bradley Hospital
Pediatric Bipolar Disorder
Omega-3 Fatty Acid Adjunctive to Open-Label Aripiprazole for the Treatment of Bipolar Disorder in Children and Adolescents
This will be a 12 week, double blind study of omega-3 fatty acids vs. placebo adjunctive to open-label aripiprazole treatment in children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) (currently…
- Trial name
- NCT00592683
- Testing
- Aripiprazole, fish oil
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Massachusetts General Hospital
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 Disorder
Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania.
Study Design This is the second study of a multiphase, multicenter trial that will comprehensively examine lithium in the treatment of pediatric participants with bipolar I disorder.
- Trial name
- Lithium2 (NCT01166425)
- Testing
- Lithium Carbonate
- Where
- 11 sites in United States
- Volunteers
- 81 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bipolar Disorder
The Treatment of Children and Adolescents With Treatment-Resistant Depression
This study seeks to learn about brain function in adolescents with depression and to determine whether adding lithium carbonate to antidepressant medication can reduce depression in children and adolescents.
- Trial name
- NCT00029640
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- National Institute of Mental Health (NIMH)
Autism, Aggression
The Family VOICE Study
Family centered mental health treatment with children values and supports the role of parents in their child's recovery. However, medications are often the primary focus in community treatment, even in preschool age youth, with…
- Conditions
- Autism, Aggression, Bipolar Disorder, Psychotic Disorders
- Trial name
- NCT01804582
- Testing
- Family Navigator consultation
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- University of Maryland, Baltimore
Omega-3 Fatty Acids, Pediatric Bipolar Disorder
Omega 3 Fatty Acid Trial
This study is being done to detect the metabolic changes that Omega 3 fatty acid treatment has on the brain and to find out whether magnetic resonance spectroscopy (MRS) scan can detect metabolic differences between bipolar…
- Conditions
- Omega-3 Fatty Acids, Pediatric Bipolar Disorder, Adolescent Bipolar Disorder, Magnetic Resonance Spectroscopy Imaging
- Trial name
- NCT00586222
- Testing
- Omega-3 Fatty Acid
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Mood Disorder
Studies of Brain Function and Course of Illness in Pediatric Bipolar Disorder
This study seeks to learn more about the symptoms of severe mood dysregulation in children and adolescents ages 7-17. Children and adolescents with severe mood dysregulation (SMD) display chronic anger, sadness, or irritability…
- Trial name
- NCT00025935
- Testing
- Lithium
- Where
- United States
- Volunteers
- 2,350 people
- Sponsor
- National Institute of Mental Health (NIMH)
Bipolar Disorder
White Matter in Pediatric Bipolar Disorder: A DTI Study
Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a clinical interview, including the KSADS-PL.
- Trial name
- NCT00391235
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Cambridge Health Alliance