NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder
China Medical University Hospital
90 participants
Oct 4, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria8
- 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
Interventions
Use of an NMDA enhancer for the treatment of bipolar depression
Use of placebo as a comparator.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05977023