NMDA Receptor Modulation for the Treatment of Bipolar I Disorder

Launched by CHINA MEDICAL UNIVERSITY HOSPITAL · Aug 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for Bipolar I Disorder (BD-I), particularly focusing on the depressive episodes that many patients experience. Researchers are looking at a special medication that enhances the function of a brain receptor called the NMDA receptor. This trial aims to see if this treatment can help improve cognitive difficulties and reduce stress for patients dealing with bipolar depression.

To participate, individuals must be between 18 and 65 years old and currently experiencing a depressive episode of BD-I. They should have already tried stable treatment with specific medications for at least four weeks. Participants will be monitored closely throughout the trial to ensure safety and effectiveness. It's important to note that individuals with certain conditions, like substance abuse or serious medical issues, may not be eligible. If you or someone you know is interested in learning more about joining this study, it could provide an opportunity to help improve treatment options for bipolar depression.

Gender

ALL

Eligibility criteria

• 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