Clinical trials: Mania
Bipolar Disorder Type I With Mania
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the…
- Trial name
- NCT06929273
- Testing
- KarXT, Lithium, Valproate
- Where
- 184 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Bristol-Myers Squibb
Bipolar 1 Disorder
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Bipolar I Disorder
This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania…
- Trial name
- NCT07046494
- Testing
- RAP-219
- Where
- 20 sites in United States
- Volunteers
- 253 people
- Sponsor
- Rapport Therapeutics Inc.
Bipolar-I Disorder With Mania or Mania With Mixed Features
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
- Trial name
- BALSAM-1 (NCT06951698)
- Testing
- KarXT
- Where
- 74 sites in United States, Argentina and 7 more
- Volunteers
- 274 people
- Sponsor
- Bristol-Myers Squibb
Bipolar Disorder Type I With Mania or Mania With Mixed Features
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.
- Trial name
- NCT06951711
- Testing
- KarXT
- Where
- 85 sites in United States, China and 9 more
- Volunteers
- 274 people
- Sponsor
- Bristol-Myers Squibb
Bipolar I Disorder, Mania
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or…
- Trial name
- NCT07288320
- Testing
- NBI-1117568
- Where
- 11 sites in United States
- Volunteers
- 150 people
- Sponsor
- Neurocrine Biosciences
Mania, Bipolar Disorder
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.
- Trial name
- NCT07140913
- Testing
- Xanomeline/Trospium Chloride
- Where
- 104 sites in United States, Argentina and 11 more
- Volunteers
- 424 people
- Sponsor
- Bristol-Myers Squibb
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
BHV-7000 Acute Treatment of Bipolar Mania
The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.
- Trial name
- NCT06419582
- Testing
- BHV-7000
- Where
- 32 sites in United States
- Volunteers
- 274 people
- Sponsor
- Biohaven Therapeutics Ltd.
Bipolar Disorder
BHV-7000 Open-Label Extension Bipolar Mania Study
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.
- Trial name
- NCT06423794
- Testing
- BHV-7000
- Where
- 32 sites in United States
- Volunteers
- 94 people
- Sponsor
- Biohaven Therapeutics Ltd.
Bipolar I Disorder, Mania
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e.
- Conditions
- Bipolar I Disorder, Mania, Depression
- Trial name
- NCT03573297
- Testing
- Cariprazine
- Where
- 108 sites in United States, Bulgaria and 9 more
- Volunteers
- 901 people
- Sponsor
- AbbVie
Bipolar Disorder, Schizophrenia
Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)
This study will assess asenapine (Sycrest®) use in participants with bipolar disorder; comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine (Zyprexa®).
- Trial name
- NCT01495741
- Volunteers
- 42 people
- Sponsor
- Organon and Co
Acute Mania, Bipolar Disorder, Manic
Ziprasidone And Olanzapine's Outcomes In Mania
The purpose of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania.
- Trial name
- ZOOM (NCT00329108)
- Testing
- ziprasidone hydrochloride, olanzapine
- Where
- 19 sites in Germany, Greece and 3 more
- Volunteers
- 29 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Mania, Bipolar Disorder
Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)
The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8…
- Trial name
- NCT00280566
- Testing
- Ziprasidone Oral Capsule
- Where
- 107 sites in United States, Chile and 11 more
- Volunteers
- 584 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Affective Psychosis, Bipolar, Mania
Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.
- Conditions
- Affective Psychosis, Bipolar, Mania, Manic-Depressive Psychosis
- Trial name
- NCT00454883
- Testing
- ziprasidone
- Volunteers
- 379 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Schizophrenia, Mania
A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania, delusional disorder and…
- Conditions
- Schizophrenia, Mania, Delusional Disorder, Acute Exacerbation of Psychosis
- Trial name
- NCT00644800
- Testing
- Ziprasidone
- Where
- 8 sites in Brazil
- Volunteers
- 89 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Disorder
Safety And Tolerability Of Flexible Doses Of Oral 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 a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).
- Trial name
- NCT01124877
- Testing
- ziprasidone oral capsules
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar I Disorder, Acute Mania
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder.
- Trial name
- NCT03287869
- Testing
- Brexpiprazole
- Where
- 73 sites in United States, Bulgaria and 4 more
- Volunteers
- 381 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Disorder, Manic Episode
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder
To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.
- Trial name
- NCT03257865
- Testing
- Brexpiprazole
- Where
- 38 sites in United States, Croatia and 1 more
- Volunteers
- 333 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Disorder, Manic Episode
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder
To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.
- Trial name
- NCT03259555
- Testing
- Brexpiprazole
- Where
- 48 sites in United States, Bulgaria and 2 more
- Volunteers
- 322 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Disorder
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
- Trial name
- NCT01059539
- Testing
- Cariprazine
- Where
- 35 sites in United States, Hungary and 2 more
- Volunteers
- 403 people
- Sponsor
- Forest Laboratories