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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

NMDAE

Use of an NMDA enhancer for the treatment of bipolar depression

DRUG

Placebo Cap

Use of placebo as a comparator.

Locations (1)

Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan