Bipolar I Disorder Clinical Trial
Official title:
NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder
At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. NMDA receptor (NMDAR) dysfunction is associated with BD-I, particularly its cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression.
Bipolar I disorder (BD-I) is a severe brain disorder. At present, the treatment of BD-I, especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression. The subjects are bipolar depression patients. They have been treated for bipolar depression for at least four weeks but remain depressive. Participating in this study, they will continue the original treatment, and will be randomized, double-blindly to receive the NMDAE or placebo for 8 weeks. We will measure 6 cognitive domains (including 9 cognitive tests) and quality of life at weeks 0 and 8; and assess the Perceived Stress Scale, Global Assessment of Function (GAF), various scales for clinical symptoms, and side effects at weeks 0, 2, 4, 6, and 8. The efficacies of NMDAE and placebo will be compared. Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03641300 -
Efficacy of Convulsive Therapies for Bipolar Depression
|
N/A | |
Withdrawn |
NCT01495156 -
Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
|
Phase 4 | |
Completed |
NCT00982020 -
Study in Adolescents With Schizophrenia or Bipolar Disorder
|
Phase 4 | |
Completed |
NCT00746343 -
Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study
|
N/A | |
Completed |
NCT00177463 -
L-Carnosine for Bipolar I Disorder
|
N/A | |
Completed |
NCT03257865 -
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder
|
Phase 3 | |
Completed |
NCT03259555 -
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder
|
Phase 3 | |
Not yet recruiting |
NCT06433635 -
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
|
Phase 4 | |
Completed |
NCT04127058 -
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
|
Phase 1 | |
Recruiting |
NCT05340686 -
Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression
|
N/A | |
Completed |
NCT03287869 -
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
|
Phase 3 | |
Enrolling by invitation |
NCT04987229 -
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
|
Phase 3 | |
Completed |
NCT00761761 -
Sensoril(Ashwaganhda)for Bipolar Disorder
|
Phase 3 | |
Completed |
NCT00232414 -
A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder
|
Phase 3 | |
Completed |
NCT03292848 -
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
|
Phase 1 | |
Active, not recruiting |
NCT04561622 -
Emotional Proactive Processing in Bipolar Disorder
|
||
Recruiting |
NCT03943537 -
Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
|
Phase 2 | |
Completed |
NCT03334721 -
Gabapentin for Bipolar & Cannabis Use Disorders
|
Phase 2 | |
Active, not recruiting |
NCT05658510 -
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
|
Phase 3 | |
Completed |
NCT00958633 -
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.
|
Phase 3 |