Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 23, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT05977023). This is a study registration, not published results. Lead sponsor: China Medical University Hospital. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: Bipolar I Disorder. Interventions: DRUG: NMDAE; DRUG: Placebo Cap. Primary outcome measures: 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; Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0 , week 0, 8; Change in Perceived Stress Scale in Perceived Stress Scale , week 0, 2, 4, 6, 8. Brief 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.