Clinical trials: Manic Disorder
Schizophrenia, Bipolar Disorder
Aripiprazole Open-Label, Safety and Tolerability Study
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
- Trial name
- APEX 241 (NCT00102518)
- Testing
- Aripiprazole
- Where
- 50 sites in United States
- Volunteers
- 325 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder, Bipolar Depression
Uridine Adolescent Bipolar Depression Randomized Controlled Trial
This is a randomized, double-blind, placebo-controlled study of the investigational drug uridine as a treatment for depressed adolescents with bipolar disorder (i.e. "bipolar depression").
- Conditions
- Bipolar Disorder, Bipolar Depression, Manic Depression
- Trial name
- NCT01805440
- Testing
- Uridine
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- University of Utah
Bipolar Disorder, Weight Gain
Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine
The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
- Trial name
- NCT00394095
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Cincinnati
Bipolar Disorder, Alcohol Abuse
Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults
The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability…
- Trial name
- NCT00550394
- Testing
- Quetiapine and Topiramate
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Cincinnati
Bipolar Disorder
Aripiprazole in Children and Adolescents With Bipolar I Disorder
The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.
- Trial name
- NCT00110461
- Testing
- Aripiprazole
- Where
- 53 sites in United States
- Volunteers
- 296 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, 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 Spectrum Disorders
Inositol and Omega-3 Fatty Acids in Pediatric Mania
The purpose of this study is to a) evaluate the efficacy of omega-3 fatty acids versus inositol in the treatment of pediatric bipolar disorder, b) evaluate the efficacy of omega-3 fatty acid plus inositol in the treatment of…
- Trial name
- NCT01396486
- Testing
- Omega-3, Inositol
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Massachusetts General Hospital
Bipolar Disorder
Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
- Trial name
- TEAM (NCT00057681)
- Testing
- Lithium carbonate, Valproate, Risperidone
- Where
- 5 sites in United States
- Volunteers
- 379 people
- Sponsor
- Washington University School of Medicine
Bipolar Disorder
Lithium and Divalproex for the Treatment of Comorbid Rapid Cycling Bipolar Disorder and Substance Abuse Disorder
This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.
- Trial name
- NCT00194129
- Testing
- Lithium, Divalproex
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University Hospitals Cleveland Medical Center
Pediatric Bipolar Disorder
Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder
This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or Bipolar Spectrum Disorder.
- Trial name
- NCT00592358
- Testing
- paliperidone
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Massachusetts General Hospital
Bipolar Disorder
Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder
This 26-week open-label extension study is designed to provide information on the safety and tolerability of oral ziprasidone (20-80 mg BID (twice daily) with meals) during long-term administration in children and adolescents…
- Trial name
- NCT03768726
- Testing
- Ziprasidone
- Where
- 9 sites in United States
- Volunteers
- 23 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Attention Deficit Disorder With Hyperactivity
Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood
This study will evaluate the effectiveness of an integrative group psychosocial therapy combined with stimulant medication in treating children with attention deficit hyperactivity disorder plus impairments in mood.
- Trial name
- NCT00632619
- Testing
- Group-based behavior therapy, Stimulant medication therapy, Community-based psychosocial treatment
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Florida International University
Bipolar Disorder, Anxiety Disorders
Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder
Pediatric Bipolar Disorder (BD) is uncommon in children. Its symptoms include periods of manic behavior (being overly happy or giddy, feeling grandiose, feeling a decreased need for sleep, having too much energy, moving more than…
- Conditions
- Bipolar Disorder, Anxiety Disorders, Bipolar Affective Disorder, Bipolar Depression
- Trial name
- NCT00805493
- Testing
- Riluzole
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- National Institute of Mental Health (NIMH)
Mania
Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania
The purpose of this study is to see if taking a substance called omega-3 fatty acids is effective, safe, and well-tolerated for treating adolescents with major depressive disorder (also called simply "depression" or "clinical…
- Trial name
- R34 (NCT00917501)
- Testing
- OMega 3
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
Bipolar Disorder, Major Depression
Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI
The purpose of the study is to find out what parts of the brain have increased or decreased activity and connectivity in individuals who have bipolar disorder, major depression, or no history of mood disorder.
- Trial name
- NCT01811147
- Testing
- Selective Serotonin Reuptake Inhibitor (SSRI)
- Where
- United States
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Schizophrenia, Mania
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
- Trial name
- NCT00102479
- Testing
- Aripiprazole
- Volunteers
- 21 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder, Mania
Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder
This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder.
- Trial name
- NCT00181883
- Testing
- quetiapine
- Volunteers
- 30 people
- Sponsor
- Massachusetts General Hospital
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
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.
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.