Clinical trials: Bipolar 1 Disorder
Bipolar I Disorder
A Multicenter Investigative Study of the Safety and Efficacy of Long-term Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
To assess the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner in patients with Bipolar I Disorder experiencing a manic or mixed…
- Trial name
- NCT00606229
- Testing
- Aripiprazole
- Where
- 5 sites in Japan
- Volunteers
- 41 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar Disorder
Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder
This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.
- Trial name
- NCT00034580
- Testing
- olanzapine, risperidone
- Where
- 21 sites in United States
- Volunteers
- 326 people
- Sponsor
- Eli Lilly and Company
Bipolar Disorder
Study Measuring Differences in Cognition Due to Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients
The purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, remember, judge, and reason) functioning in…
- Trial name
- NCT00097032
- Testing
- risperidone; quetiapine
- Volunteers
- 30 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bipolar Disorder, Mood Disorders
A Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-release Paliperidone in Subjects With Bipolar I Disorder
The purpose of this study is to evaluate the effectiveness and safety of 3 different doses of paliperidone extended release (ER) compared to placebo in patients diagnosed with Bipolar I Disorder who are experiencing an acute…
- Trial name
- NCT00299715
- Testing
- Paliperidone extended-release
- Volunteers
- 473 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Acute Agitation
Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INP105, which is an investigational drug-device combination product comprised of the drug component OLZ administered by a…
- Trial name
- SNAP101 (NCT03624322)
- Testing
- Zyprexa IM, Zydis, INP105
- Where
- Australia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Impel Pharmaceuticals
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
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, 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.
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
Schizophrenia, Bipolar I Disorder
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral…
- Conditions
- Schizophrenia, Bipolar I Disorder, Major Depressive Disorder
- Trial name
- NCT07185815
- Testing
- Cariprazine Depot, Cariprazine Depot MTD, Oral Cariprazine 3 mg/day
- Where
- 6 sites in India, Israel
- Volunteers
- 24 people
- Sponsor
- Mapi Pharma Ltd.
Bipolar Disorder, Depression
Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I…
- Trial name
- NCT02670538
- Testing
- Cariprazine
- Where
- 89 sites in United States, Bulgaria and 6 more
- Volunteers
- 493 people
- Sponsor
- Forest Laboratories
Bipolar Disorder
An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients
This study is planned to objectively assess the efficacy and safety of lamotrigine maintenance therapy after symptoms of mood episode had been stabilised by open-label treatment with lamotrigine alone or in combination with other…
- Trial name
- NCT00550407
- Testing
- lamotrigine
- Where
- 60 sites in Japan
- Volunteers
- 215 people
- Sponsor
- GlaxoSmithKline
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.
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.
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.
Bipolar Disorder
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder.
- Trial name
- NCT00107939
- Testing
- Licarbazepine
- Where
- 22 sites in United States
- Volunteers
- 453 people
- Sponsor
- Novartis Pharmaceuticals
Bipolar I Disorder
A Study of Elpipodect (MK-8189) in Participants With Bipolar I Disorder (MK-8189-020)
The goal of this study is to evaluate the safety and tolerability of elpipodect in participants with stable bipolar I disorder. There was no hypothesis testing in this study.
- Trial name
- NCT06273774
- Testing
- Elpipodect
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
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
Anxiety, Depression
Ginger.io Behavioral Health Study
This Study will evaluate the impact of a smartphone-based platform on a range of outcomes for medically-underserved patients with mood disorders (e.g.
- Conditions
- Anxiety, Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- NCT02491307
- Testing
- Ginger.io Smartphone Application
- Where
- 4 sites in United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Community Health Center, Inc.