RecruitingPhase 2NCT05977023

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


Sponsor

China Medical University Hospital

Enrollment

90 participants

Start Date

Oct 4, 2023

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug that works on NMDA receptors (a brain chemical pathway) helps relieve depression in people with Bipolar I disorder. It is added on top of existing stable mood medications. **You may be eligible if...** - You are 18–65 years old - You have been diagnosed with Bipolar I disorder and are currently experiencing a depressive episode - You have been on a stable dose of an antipsychotic (quetiapine or lurasidone) and/or mood stabilizer for at least 4 weeks - Your depression is at least moderate in severity on a standard rating scale - Your manic symptoms are minimal **You may NOT be eligible if...** - You have a history of substance abuse in the past 6 months - You have epilepsy, a history of significant head trauma, stroke, or other serious neurological condition - You have a diagnosis of schizophrenia or another psychotic disorder - You have moderate-to-severe suicidal risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNMDAE

Use of an NMDA enhancer for the treatment of bipolar depression

DRUGPlacebo Cap

Use of placebo as a comparator.


Locations(1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

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NCT05977023


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