NMDA Receptor Modulation for the Treatment of Bipolar I Disorder

Phase

Condition

N/A

Treatment

Placebo Cap

NMDAE

Clinical Study ID

NCT05977023

CMUH111-REC2-222

Ages 18-65
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Are 18 to 65 years of age;
Satisfy a DSM-5-TR (American Psychiatric Association) diagnosis of BD-I, currentepisode depressed, after treatment of stable (i.e., at least 4 weeks) and adequatetreatment of antipsychotic (quetiapine or lurasidone) and/or mood stabilizer;
Have a 17-item Hamilton Depression Rating Scale (HAMD) score ≥18 and a Young ManiaRating Scale (YMRS) score ≤7 at baseline;
Agree to participate in the study and provide informed consent

Exclusion

Exclusion Criteria:

Current substance abuse or history of substance dependence in the past 6 months
History of epilepsy, head trauma, stroke or other serious medical or neurologicalillness which may interfere with the study
Schizophrenia or other psychotic disorder
Moderate-severe suicidal risks
Severe cognitive impairment
Clinically significant laboratory screening tests (including blood routine,biochemical tests)
Pregnancy or lactation;
Inability to follow protocol

Study Design

Placebo Cap

October 04, 2023

December 31, 2027

Study Description

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.

Connect with a study center

Department of Psychiatry, China Medical University Hospital
Taichung,
Taiwan
Active - Recruiting

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