Clinical trials: Patients With Bipolar Disorders
Sleep Initiation and Maintenance Disorders
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.
- Trial name
- NCT00374777
- Testing
- zolpidem MR, nitrazepam
- Where
- 6 sites in Japan
- Volunteers
- 450 people
- Sponsor
- Astellas Pharma Inc
Bipolar Disorder
Valproic Acid Sodium Salt in Bipolar Disorder
To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA) levels in patients with bipolar disorders who are within euthimic, depressive or manic/hypomanic period and who are not taking drug; To…
- Trial name
- NCT00431522
- Testing
- Valproic acid, sodium salt
- Where
- Turkey (Türkiye)
- Volunteers
- 58 people
- Sponsor
- Sanofi
Bipolar Disorder
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
- Trial name
- NCT00277212
- Testing
- Lamotrigine + Aripiprazole
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 1,169 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder, Depression
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder.
- Trial name
- NCT02670551
- Testing
- Cariprazine
- Where
- 74 sites in United States, Bulgaria and 4 more
- Volunteers
- 488 people
- Sponsor
- Forest Laboratories
Bipolar Disorder
Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.
- Trial name
- NCT00321516
- Testing
- aripiprazole
- Where
- 4 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Schizoaffective Disorder
Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia
This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depressive Disorder
- Trial name
- NCT05859698
- Testing
- Valbenazine
- Where
- 18 sites in United States
- Volunteers
- 59 people
- Sponsor
- Neurocrine Biosciences
Depression, Bipolar
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.
- Trial name
- NCT01396447
- Testing
- Cariprazine
- Where
- 88 sites in United States, Bulgaria and 4 more
- Volunteers
- 584 people
- Sponsor
- Forest Laboratories
Bipolar Depression
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar…
- Trial name
- NCT02600507
- Testing
- Lumateperone (ITI-007)
- Where
- 71 sites in United States, Bulgaria and 3 more
- Volunteers
- 529 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Comparing Hospitalisation Time With Seroquel and Seroquel Prolong
Nis Register Study Comparing Seroquel and Seroquel Prolong
The general aim of this non interventional study is to clarify what are the current clinical treatment practices of Quetiapine Immediate Release and Quetiapine Extended Release.
- Trial name
- NCT00965536
- Where
- Finland
- Volunteers
- 200 people
- Sponsor
- AstraZeneca
Bipolar Disorder
3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)
Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes).
- Trial name
- NCT00159744
- Testing
- Asenapine, Olanzapine
- Volunteers
- 488 people
- Sponsor
- Organon and Co
Bipolar Disorder
A Randomized, Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar Disorder
The purpose of this study is to determine the safety and effectiveness of a long-acting injectable formulation of risperidone in stable bipolar patients randomly switched from their current add-on oral antipsychotic (olanzapine…
- Trial name
- NCT00246246
- Testing
- risperidone
- Volunteers
- 48 people
- Sponsor
- Janssen-Ortho Inc., Canada
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 Depression
Quetiapine Efficacy in Bipolar Depression Study
To reassure the clinical study data on Seroquel antidepressant efficacy in patients who are diagnosed as bipolar depression
- Trial name
- QUEEN (NCT00523601)
- Where
- 3 sites in South Korea
- Volunteers
- 2,000 people
- Sponsor
- AstraZeneca
Affective Psychosis, Bipolar, Bipolar Disorder
A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder
The purpose of this study is to evaluate the effectiveness and safety over a 6-week period of paliperidone ER compared with placebo in treating subjects with Bipolar I Disorder who are experiencing a manic or mixed episode while…
- Conditions
- Affective Psychosis, Bipolar, Bipolar Disorder, Mania
- Trial name
- NCT00309686
- Testing
- Paliperidone ER
- Volunteers
- 300 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bipolar I Disorder
A Multicenter, Investigative Study of the Safety and Efficacy of Extended 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 by performing extended administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner to those…
- Trial name
- NCT00606320
- Testing
- Aripiprazole
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 59 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Bipolar Disorder, Manic
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with…
- Trial name
- NCT06462586
- Testing
- Lumateperone
- Where
- 42 sites in United States, Bulgaria and 3 more
- Volunteers
- 354 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Bipolar Disorder
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling
The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling.
- Trial name
- NCT00254774
- Testing
- quetiapine fumarate or valproate
- Where
- 3 sites in Germany
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Bipolar Disorder, Schizophrenia
Non Interventional Study In Bipolar Disorder And Schizophrenia With Zeldox
Investigation of the impact of Zeldox on metabolic parametres in patients with bipolar disorder or with schizophrenia and impact of the treatment for the quality of life
- Trial name
- NCT00538629
- Testing
- no intervention
- Volunteers
- 471 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bipolar Depression, Suicidal Ideation
NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression
NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. NeuroRx has developed a sequential therapy consisting of IV NRX-100 (ketamine HCL) for rapid stabilization of…
- Trial name
- SevereBD (NCT03396601)
- Testing
- Ketamine Hydrochloride
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- NeuroRx, Inc.
Acute Depressive Episode
Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder
The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult participants with acute depressive episodes associated with Bipolar I disorder.
- Trial name
- NCT01467700
- Testing
- Ramelteon SL
- Where
- 161 sites in United States, Argentina and 3 more
- Volunteers
- 490 people
- Sponsor
- Takeda