NMDA Receptor Modulation for the Treatment of Bipolar I Disorder

NCT05977023 · tracked via the Priya Life Science China tracker

Sponsor

China Medical University Hospital

Phase

Phase 2

Started

2023-10-04

Last updated

2025-02-19

Condition(s) studied

Bipolar I Disorder

Investigational drug(s) / intervention(s)

NMDAE →Placebo Cap

NMDAE: Use of an NMDA enhancer for the treatment of bipolar depression

Placebo Cap: Use of placebo as a comparator.

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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Change in Visual Continuous Performance Test — week 0, 8
Assessment of sustained attention
Change in Wisconsin Card Sorting Test — week 0, 8
Assessment of abstract and shift set
Change in Logical Memory Test of the Wechsler Memory Scale — week 0, 8
Assessment of episodic memory
Digit Span — week 0, 8
Assessment of verbal working memory
Spatial Span — week 0, 8
Assessment of nonverbal working memory
Category Fluency — week 0, 8
Assessment of speed of processing
Trail Marking A — week 0, 8
Assessment of speed of processing
WAIS-III Digit Symbol-Coding — week 0, 8
Assessment of speed of processing
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0 — week 0, 8
Assessment of social cognition
Change in Perceived Stress Scale in Perceived Stress Scale — week 0, 2, 4, 6, 8
Assessment of stress and anxiety symptoms Minimum value: 0, maximum value:56, the higher scores mean a worse outcome.

Trial sites (1)

Facility	City	Region	Status
Department of Psychiatry, China Medical University Hospital	Taichung	Taiwan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05977023 on ClinicalTrials.gov ↗ ← All trials in China