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NMDA Receptor Modulation for the Treatment of 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…

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ClinicalTrials.gov IDNCT05977023

PhasePHASE2

Enrollment90

SponsorChina Medical University Hospital

Age18 Years – 65 Years

SexALL

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Conditions studied

Bipolar I Disorder

About this study

Interventions

Drug: NMDAE — Use of an NMDA enhancer for the treatment of bipolar depression
Drug: Placebo Cap — Use of placebo as a comparator.

Primary outcomes

Change in Visual Continuous Performance Test (week 0, 8)
Change in Wisconsin Card Sorting Test (week 0, 8)
Change in Logical Memory Test of the Wechsler Memory Scale (week 0, 8)
Digit Span (week 0, 8)
Spatial Span (week 0, 8)
Category Fluency (week 0, 8)
Trail Marking A (week 0, 8)
WAIS-III Digit Symbol-Coding (week 0, 8)

Eligibility information

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

Study locations

Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-12.