Clinical trials: Bipolar Disorder I
Bipolar Disorder
Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression
The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar depression.
- Trial name
- NCT00485771
- Testing
- Olanzapine, Fluoxetine, Lamotrigine
- Where
- United States
- Volunteers
- 403 people
- Sponsor
- Eli Lilly and Company
Schizophrenia, Schizo Affective Disorder
Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)
To characterize the real-life clinical use of AOM in a hospitalized patient population with schizophrenia, schizoaffective disorder or BP1 requiring LAI therapy and evaluate its short-term effectiveness associated with its…
- Conditions
- Schizophrenia, Schizo Affective Disorder, Bipolar I Disorder
- Trial name
- INITIATE (NCT04907279)
- Testing
- Aripiprazole Once-Monthly (AOM)
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- Otsuka Canada Pharmaceutical Inc.
Bipolar I Disorder, Mania
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving manic symptoms in adults with bipolar I disorder who are currently experiencing an episode of mania with or…
- Trial name
- NCT07288320
- Testing
- NBI-1117568
- Where
- 11 sites in United States
- Volunteers
- 150 people
- Sponsor
- Neurocrine Biosciences
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
Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day…
- Trial name
- NCT00139074
- Testing
- Quetiapine fumarate, sodium valproate
- Where
- 7 sites in Denmark
- Volunteers
- 17 people
- Sponsor
- AstraZeneca
Bipolar Disorder
Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or Mixed).
- Trial name
- NCT01117220
- Testing
- Ziprasidone Oral Capsules
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris 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
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.
Treatment for Bipolar I Disorder
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.
- Trial name
- NCT01570907
- Testing
- Quetiapine Fumarate
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Depressive Disorder, Depressive Disorder, Major
Synaptic Imaging and Network Activity in Treatment Resistant Depression
The main aim of this research is to explore the effects that ketamine has on the functional connectivity of the brain in participants with treatment resistant depression (TRD).
- Conditions
- Depressive Disorder, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Bipolar Disorder
- Trial name
- SIGNATURE (NCT05870501)
- Testing
- Ketamine, Midazolam
- Where
- United Kingdom
- Volunteers
- 56 people
- Sponsor
- King's College London
Bipolar Disorder
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.
Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with…
- Trial name
- NCT00154323
- Testing
- Oxcarbazepine
- Volunteers
- 55 people
- Sponsor
- Novartis
Bipolar Disorder Type I With Mania
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the…
- Trial name
- NCT06929273
- Testing
- KarXT, Lithium, Valproate
- Where
- 184 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Bristol-Myers Squibb
Bipolar Disorder, Type 1
Evaluation of Theta-burst Stimulation Efficacy, Safety and Tolerability in Major Depressive Episodes of Bipolar I Disorder
INTRODUCTION: Pharmacological treatment of major depressive episodes in bipolar disorder (BD) is characterized by suboptimal efficacy rates, poor tolerability and adherence, delayed onset of action, and iatrogenic mood swings.
- Trial name
- NCT05501626
- Testing
- Active Theta Burst Stimulation (TBS)
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- University of Sao Paulo
Nicotine Dependence
Study of Varenicline (Champix) for Smoking Cessation/Reduction in Patients With Bipolar Disorder
Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression.
- Trial name
- NCT01093937
- Testing
- varenicline
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Centre for Addiction and Mental Health
Type 2 Diabetes Mellitus, Schizophrenia
Lifestyle Intervention for Diabetes and Weight Management in Psychosis
The rate of type-2 diabetes mellitus (T2DM) is at least 2-3 times higher in persons with psychotic illnesses than in the general population.
- Conditions
- Type 2 Diabetes Mellitus, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- Trial name
- Healthy_LIFE (NCT01828931)
- Testing
- Lifestyle Intervention, Usual Care
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- Centre for Addiction and Mental Health
Bipolar I Disorder, Bipolar II Disorder
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with…
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder
- Trial name
- NCT07116694
- Testing
- BXCL501 Sublingual Film
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- BioXcel Therapeutics Inc
Bipolar I Disorder
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.
- Trial name
- NCT00094432
- Testing
- Aripiprazole
- Where
- 40 sites in United States
- Volunteers
- 650 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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 Disorder, Insomnia
Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder
Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression.
- Trial name
- NCT01704352
- Testing
- Cognitive behavioral therapy for insomnia
- Where
- Norway
- Volunteers
- 38 people
- Sponsor
- Norwegian University of Science and Technology
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