Clinical trials: Bipolar 1 Disorder
Depressive Episode, Bipolar 1 Depression
A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression
A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression
- Trial name
- NCT03543410
- Testing
- SEP-4199 200 mg, SEP-4199 400 mg
- Where
- 87 sites in United States, Bulgaria and 6 more
- Volunteers
- 344 people
- Sponsor
- Sumitomo Pharma America, Inc.
Depressive Episodes, Bipolar I Depression
A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression).
- Trial name
- NCT05227209
- Testing
- SEP-4199 CR
- Where
- 69 sites in United States, Bulgaria and 1 more
- Volunteers
- 64 people
- Sponsor
- Sumitomo Pharma America, 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.
Schizophrenia, Schizoaffective Disorder
Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome
The purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar I Disorder, Metabolic Syndrome
- Trial name
- NCT00857818
- Testing
- Aripiprazole, Oanzapine, risperidone, or quetiapine
- Where
- 14 sites in Canada
- Volunteers
- 64 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Disorder
Risperdal Consta for Bipolar Disorder
We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent.
- Trial name
- NCT00177164
- Testing
- Injectable Risperidone (Consta) or oral antipsychotic
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Pittsburgh
Depressive Episodes, Bipolar I Depression
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive…
- Trial name
- NCT05169710
- Testing
- SEP-4199 CR 200 mg, SEP-4199 CR 400 mg
- Where
- 89 sites in United States, Bulgaria and 4 more
- Volunteers
- 83 people
- Sponsor
- Sumitomo Pharma America, 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.
Bipolar Disorder
Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.
- Trial name
- NCT00129220
- Testing
- olanzapine, haloperidol
- Where
- 16 sites in Japan
- Volunteers
- 224 people
- Sponsor
- Eli Lilly and Company
Bipolar Disorder, Mania
Safety and Efficacy of Cariprazine for Mania
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
- Trial name
- NCT01058096
- Testing
- Cariprazine
- Where
- 28 sites in United States, India
- Volunteers
- 323 people
- Sponsor
- Forest Laboratories
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.
Depression
A Study of Infliximab for Treatment Resistant Major Depression
Major depression is increasingly recognized to be a chronic and highly recurrent condition, which results in significantly increased health problems.
- Trial name
- Infliximab (NCT00463580)
- Testing
- Infliximab
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Emory University
Bipolar Disorder
Effect of Pharmaceutical Care in Patients With Bipolar I Disorder (BD I)
This project aims, through pharmaceutical care in patients with Bipolar I Disorder, improve compliance and adherence rate, associated with greater effectiveness and safety of drug therapy to help achieve therapeutic goals, and…
- Trial name
- EMDADER-TABI (NCT01750255)
- Testing
- Pharmaceutical Care, Education
- Where
- Colombia
- Volunteers
- 92 people
- Sponsor
- Universidad de Antioquia
Bipolar I Disorder
Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients
This will be a randomized, double-blind, placebo-controlled trial to assess the time to recurrence of any mood episode in subjects with bipolar I disorder who have maintained stability on aripiprazole IM depot for at least 8…
- Trial name
- NCT01567527
- Testing
- Intramuscular (IM) Depot Aripiprazole
- Where
- 76 sites in United States, Canada and 5 more
- Volunteers
- 731 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, 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.
Bipolar I Disorder, Bipolar II Disorder
Sequential Multiple Assignment Treatment for Bipolar Disorder
The purpose of this study is to compare which of the two mood stabilizers (drugs that help to steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is more effective in patients with bipolar…
- Trial name
- SMART (NCT01588457)
- Testing
- Lithium, Divalproex, Lamotrigine
- Where
- 2 sites in United States
- Volunteers
- 112 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Mania, Bipolar I Disorder
Safety and Efficacy of Cariprazine for Bipolar I Disorder
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
- Trial name
- NCT01058668
- Testing
- Cariprazine
- Where
- 66 sites in United States, Croatia and 4 more
- Volunteers
- 497 people
- Sponsor
- Forest Laboratories
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.