Clinical trials: Bipolar I Depression
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
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.
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, 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
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
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.
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, Bipolar Depression
Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression
This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases.
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- NCT03603561
- Testing
- cTBS
- Where
- 2 sites in Belgium
- Volunteers
- 40 people
- Sponsor
- Universiteit Antwerpen
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.
Bipolar Depression
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B.
- Trial name
- NCT02600494
- Testing
- ITI-007 (Lumateperone)
- Where
- 55 sites in United States
- Volunteers
- 554 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Treatment Resistant Depression
Effect of Lithium Versus Placebo in Adults With Treatment-Resistant Depression Who Are Receiving Ketamine
The purpose of this research study is to compare the antidepressant effect of lithium versus placebo in adults receiving ketamine.
- Trial name
- NCT03290963
- Testing
- Lithium, Ketamine
- Where
- United States
- Sponsor
- William V. Bobo, M.D.
Bipolar Disorder, Bipolar I Disorder
Using Neuroplasticity-Based Computerized Training to Improve Emotion Regulation in Bipolar Disorder (BRAINS)
The goal of this study is to evaluate the feasibility and potential benefit of a behavioral intervention designed to improve emotion regulation in individuals with bipolar disorder.
- Conditions
- Bipolar Disorder, Bipolar I Disorder, Bipolar Affective Disorder, Bipolar Disorder I
- Trial name
- BRAINS (NCT05683431)
- Testing
- Cognitive Control of Emotion (CCE) Training
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Depression
A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment 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
- NCT01072929
- Testing
- Armodafinil
- Where
- 40 sites in United States
- Volunteers
- 433 people
- Sponsor
- Cephalon
Depression
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment 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
- NCT01072630
- Testing
- Armodafinil
- Where
- 92 sites in United States, Argentina and 8 more
- Volunteers
- 492 people
- Sponsor
- Cephalon
Bipolar Depression
Brexpiprazole Treatment for Bipolar I Depression
Bipolar disorder (BD) is a frequent and lifelong recurrent mood disorder with treatment-resistant depressive episodes. Importantly, depressive symptoms and cognitive decline are major determinants of functionality and quality of…
- Trial name
- NCT04569448
- Testing
- Brexpiprazole
- Where
- 3 sites in Canada
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Douglas Mental Health University Institute
Bipolar Depression
Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression
The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.
- Trial name
- NCT00322764
- Testing
- Uridine
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Repligen Corporation
Bipolar Disorder, Bipolar Depression
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a…
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- X-CEED (NCT07172516)
- Testing
- Azetukalner
- Where
- 44 sites in United States, Bulgaria and 2 more
- Volunteers
- 400 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Bipolar Affective Disorder
Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II.
Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving…
- Trial name
- NCT07412132
- Testing
- Lacosamide
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- University of Sao Paulo
Bipolar I Disorder
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.
Patients with bipolar I disorder (BD) experience depression 3 times more frequently than mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of patients.
- Trial name
- NCT00958633
- Testing
- Escitalopram, Bupropion XL
- Where
- Canada
- Volunteers
- 237 people
- Sponsor
- University of British Columbia