Clinical trials: Bipolar 1 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
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
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 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.
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, 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
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.
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.
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.
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.
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, 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
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
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 Depression
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
The main goal of this study is to help answer the following research question(s) and not to treat the child's illness. Can this study drug make children with bipolar depression feel better? Does this study drug work better than a…
- Trial name
- NCT00844857
- Testing
- Olanzapine Fluoxetine Combination (OFC)
- Where
- 7 sites in United States, Russia
- Volunteers
- 291 people
- Sponsor
- Eli Lilly and Company
Bipolar I Disorder
Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
This was an extension study consisting of 2 parts. In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
- Trial name
- NCT01825837
- Testing
- BIA 2-093 1800 mg once daily [Group 1 (Part II)], BIA 2-093 900 mg once daily [Group 2 (Part II)], BIA 2-093 300 mg once daily [Group 3 (Part II)]
- Volunteers
- 104 people
- Sponsor
- Bial - Portela C S.A.