Clinical trials: Bipolar I Disorder
Bipolar Depression
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective…
- Trial name
- PREVAIL3 (NCT01284517)
- Testing
- Lurasidone
- Where
- 75 sites in United States, Canada and 8 more
- Volunteers
- 356 people
- Sponsor
- Sumitomo Pharma America, Inc.
Bipolar 1 Disorder
Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)
This study is being done to evaluate the efficacy and safety of asenapine as compared to placebo in preventing the recurrence of mood episodes after stabilization of an acute/manic mixed episode in participants with Bipolar 1…
- Trial name
- NCT01396291
- Testing
- asenapine
- Where
- 80 sites in United States, Bulgaria and 8 more
- Volunteers
- 561 people
- Sponsor
- Forest Laboratories
Bipolar I Disorder, Alcohol Dependence
Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol…
- Trial name
- NCT00114686
- Testing
- Quetiapine fumarate, lithium, divalproex
- Where
- 38 sites in United States
- Volunteers
- 350 people
- Sponsor
- AstraZeneca
Bipolar Depression
Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release
This study will be a Proof of Mechanism (POM) study to establish evidence of central pharmacodynamic activity for PF 04455242, and will be a parallel group, randomized, double blind, sponsor open study conducted in healthy male…
- Trial name
- NCT00988949
- Testing
- PF-04455242, spiradoline
- Where
- Singapore
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Schizophrenia, Bipolar Disorder
A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders
The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
- Conditions
- Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
- Trial name
- NCT00650611
- Testing
- Ziprasidone
- Where
- 17 sites in United States
- Volunteers
- 63 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Acute Agitation
A Study of Olanzapine in Patients With Acute Agitation
The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.
- Trial name
- NCT05803642
- Testing
- Olanzapine, Haloperidol
- Volunteers
- 318 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Bipolar Disorder I or II
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.
- Trial name
- NCT00259272
- Testing
- olanzapine
- Where
- 16 sites in France
- Volunteers
- 141 people
- Sponsor
- Eli Lilly and Company
Major Depressive Disorder, Bipolar I and Bipolar II
Bipolar Proteomic Assay Validation Study
The purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive episode.
- Trial name
- NCT02746367
- Testing
- Diagnostic test (LDT)
- Where
- 5 sites in United States
- Volunteers
- 261 people
- Sponsor
- Myriad Genetic Laboratories, Inc.
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
Lamictal Bipolar Observational Study
This is multi-center, prospective, observational stud. This study is designed to evaluate the rate of non-serious rash in Korean bipolar I patients.
- Trial name
- NCT00460226
- Testing
- lamotrigine
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Bipolar Disorder
Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depression Episode
The purpose of this study is to evaluate flexible doses (5-30mg) of aripiprazole versus placebo in patients with bipolar depression.
- Trial name
- NCT00080314
- Testing
- Aripiprazole
- Where
- 28 sites in United States
- Volunteers
- 400 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar I Disorder
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
- Trial name
- NCT01986114
- Testing
- SM-13496
- Where
- 8 sites in Japan, Lithuania and 6 more
- Volunteers
- 495 people
- Sponsor
- Sumitomo Pharma Co., Ltd.
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
Quetiapine Fumarate Bipolar Maintenance Monotherapy
This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in…
- Trial name
- SPaRCLe (NCT00314184)
- Testing
- quetiapine fumarate
- Where
- 95 sites in United States, Argentina and 13 more
- Volunteers
- 1,255 people
- Sponsor
- AstraZeneca
Bipolar I Disorder
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder.
- Trial name
- NCT00107731
- Testing
- quetiapine fumarate, lithium, divalproex
- Where
- 166 sites in United States, Australia and 16 more
- Volunteers
- 710 people
- Sponsor
- AstraZeneca
Bipolar Disorder
An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has considerable economic impact on our society.
- Trial name
- NCT00106405
- Testing
- Memantine HCl
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Forest Laboratories
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
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder.
- Trial name
- NCT07540338
- Testing
- AL001, Lithium carbonate
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Alzamend Neuro, Inc.
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 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