Clinical trials: Pediatric Bipolar Disorder
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
Schizophrenia, Autism
Pediatric Open-Label Extension Study
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have…
- Conditions
- Schizophrenia, Autism, Bipolar Depression
- Trial name
- NCT01914393
- Testing
- Lurasidone 20, 40, 60, 80 mg, flexibly dosed
- Where
- 88 sites in United States, Bulgaria and 13 more
- Volunteers
- 702 people
- Sponsor
- Sumitomo Pharma America, Inc.
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, 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)
Schizophrenia, Bipolar Disorder
A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events…
- Conditions
- Schizophrenia, Bipolar Disorder, Autistic Disorder, Conduct and Other Disruptive Behavior Disorders
- Trial name
- NCT01050582
- Testing
- Risperidone, Other atypical antipsychotic drugs
- Where
- 28 sites in United States, Belgium and 4 more
- Volunteers
- 244 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
Bipolar Depression
Pediatric Bipolar Depression
The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with…
- Trial name
- NCT00811473
- Testing
- Quetiapine XR
- Where
- 48 sites in United States, Colombia and 5 more
- Volunteers
- 193 people
- Sponsor
- AstraZeneca
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.
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 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
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
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.
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
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
Ziprasidone in Pediatric Bipolar Disorder
This is a 6 week, open-label, blinded-rater, randomized, controlled, pilot study designed to determine the dosing, safety and efficacy of ziprasidone in the treatment of pediatric bipolar disorder (PBD).
- Trial name
- NCT00622739
- Testing
- Ziprasidone
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Baylor College of Medicine
Bipolar Disorder
Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar
The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.
- Trial name
- NCT00176202
- Testing
- Divalproex Sodium, risperidone
- Where
- 3 sites in United States
- Volunteers
- 65 people
- Sponsor
- University of Illinois Chicago