Clinical trials: Bipolar Disorder I
Bipolar 1 Disorder, Schizophrenia
Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia
The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are currently on treatment with oral aripiprazole.
- Conditions
- Bipolar 1 Disorder, Schizophrenia, Mental Disorder, Nervous System Disorders
- Trial name
- NCT02050854
- Where
- 5 sites in United States
- Volunteers
- 47 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
Schizophrenia, Bipolar 1 Disorder
A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls.
- Conditions
- Schizophrenia, Bipolar 1 Disorder, Major Depressive Disorder
- Trial name
- NCT03643159
- Testing
- Abilify MyCite - Digital Medicine System, Aripiprazole or other oral antipsychotics
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Depression
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major…
- Trial name
- NCT01305408
- Testing
- Armodafinil
- Where
- 130 sites in United States, Argentina and 12 more
- Volunteers
- 399 people
- Sponsor
- Cephalon
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
Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
A clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.
- Trial name
- NCT00076115
- Testing
- Risperidone
- Volunteers
- 13 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Manic or Mixed Episode Associated With Bipolar I Disorder
Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be examined.
- Trial name
- NCT00266630
- Testing
- olanzapine, lithium, valproate
- Where
- 11 sites in Japan
- Volunteers
- 139 people
- Sponsor
- Eli Lilly and Company
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.
Bipolar Disorder
Olanzapine vs. Comparator and Placebo in the Treatment of Patients With Bipolar I Disorder
The goals of this study are: A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania. B.
- Trial name
- NCT00094549
- Testing
- olanzapine, divalproex sodium
- Where
- 42 sites in United States, Lithuania and 3 more
- Volunteers
- 500 people
- Sponsor
- Eli Lilly and Company
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 Disorder, Mood Disorders
A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder
The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute…
- Trial name
- NCT00309699
- Testing
- Quetiapine, Paliperidone ER
- Where
- 47 sites in United States, Greece and 6 more
- Volunteers
- 493 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bipolar I Disorder, Bipolar II Disorder
A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States.
- Trial name
- NCT06696755
- Testing
- Icalcaprant
- Where
- 33 sites in United States
- Volunteers
- 195 people
- Sponsor
- AbbVie
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 I Disorder, Schizophrenia
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
To evaluate the long-term safety and tolerability of OLZ/SAM in pediatric subjects with schizophrenia or Bipolar I disorder
- Trial name
- NCT04987229
- Testing
- OLZ/SAM
- Where
- 35 sites in United States, Argentina and 3 more
- Volunteers
- 236 people
- Sponsor
- Alkermes, Inc.
Bipolar I Disorder
Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE.
Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo).
- Trial name
- Illuminate1 (NCT07494305)
- Testing
- LB-102
- Where
- 26 sites in United States
- Volunteers
- 320 people
- Sponsor
- LB Pharmaceuticals Inc.
Schizophrenia, Bipolar I Disorder
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
- Trial name
- NCT05303064
- Testing
- OLZ/SAM, Olanzapine
- Where
- 47 sites in United States, Argentina and 3 more
- Volunteers
- 220 people
- Sponsor
- Alkermes, Inc.
Schizophrenia, Bipolar Disorder
A Drug Interaction Study of Valproic Acid and Paliperidone Extended-Release (ER) in Patients With Schizophrenia, Bipolar I Disorder, or Schizoaffective Disorder
The purpose of this study is to evaluate the potential effect of multiple oral doses of an extended release formulation of paliperidone on the pharmacokinetics (blood levels) of valproic acid (VPA) in patients with schizophrenia…
- Conditions
- Schizophrenia, Bipolar Disorder, Psychotic Disorders
- Trial name
- NCT01094249
- Testing
- divalproex sodium ER/paliperidone ER
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Bipolar Disorder
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.
- Trial name
- NCT00132678
- Testing
- Risperdal Consta
- Where
- 51 sites in United States, Austria and 8 more
- Volunteers
- 559 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.