Clinical trials: Bipolar Disorder I
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, Affective Disorders, Psychotic
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.
- Conditions
- Bipolar Disorder, Affective Disorders, Psychotic, Mood Disorders, Mental Disorders
- Trial name
- NCT00035802
- Testing
- Topiramate
- Volunteers
- 13 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bipolar Depression
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as…
- Trial name
- NCT06372964
- Testing
- Lumateperone
- Where
- 68 sites in United States, Colombia and 2 more
- Volunteers
- 384 people
- Sponsor
- Intra-Cellular Therapies, Inc.
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.
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)
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 Spectrum Disorder
Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder
The objective of this study is to compare the safety and effectiveness of Risperidone, Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks and then over an extension…
- Trial name
- NCT00182013
- Testing
- Risperidone, Olanzapine, Quetiapine
- Volunteers
- 106 people
- Sponsor
- Massachusetts General Hospital
Bipolar Disorder I
Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)
To investigate the safety for an observation period of 52 weeks with use of Abilify prolonged release aqueous suspension for intramuscular (IM) injection in patients with bipolar I disorder for prevention of recurrence/relapse of…
- Trial name
- NCT04812379
- Testing
- Abilify prolonged release aqueous suspension for IM injection (Aripiprazole)
- Where
- Japan
- Volunteers
- 535 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar Disorder
A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder
This primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with lithium or placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.
- Trial name
- NCT00037674
- Testing
- Topiramate
- Volunteers
- 434 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bipolar I Disorder
Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features.
- Trial name
- NCT01495156
- Testing
- Lithium treatment in combination with a SGA (Second Generation Antipsychotic)
- Where
- United States
- Sponsor
- Northwell Health
Schizophreniform Disorder, Bipolar I Disorder
Prevention of Weight Gain in Early Psychoses
The purpose of this study is to determine whether individuals with psychotic spectrum disorders ( Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II),Major…
- Conditions
- Schizophreniform Disorder, Bipolar I Disorder, Bipolar II Disorder, Major Depressive Disorder
- Trial name
- NCT01075295
- Testing
- Behavioural Intervention for the Prevention of Weight Gain, TAU
- Where
- Canada
- Volunteers
- 70 people
- Sponsor
- Centre for Addiction and Mental Health
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
Schizophrenia, Schizo-Affective Disorder
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
- Conditions
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I
- Trial name
- NCT05025605
- Testing
- BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
- Where
- 5 sites in United States
- Volunteers
- 140 people
- Sponsor
- BioXcel Therapeutics Inc
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.
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.
Bipolar I Disorder
Atypical Antipsychotics for Continuation and Maintenance Treatment After an Acute Manic Episode
Hypothesis: Continuation of an atypical antipsychotic medication in combination with a Mood Stabilizer, following remission from an acute manic episode, lowers the rates of relapse and recurrence of mood episodes compared to…
- Trial name
- NCT01977300
- Testing
- Valproate, Lithium, Risperidone
- Where
- Canada
- Volunteers
- 159 people
- Sponsor
- University of British Columbia
Bipolar Disorders, Mood Disorders
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.
- Conditions
- Bipolar Disorders, Mood Disorders, Affective Disorders, Psychotic
- Trial name
- NCT00240721
- Testing
- topiramate
- Volunteers
- 363 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.