Status:
RECRUITING
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
Lead Sponsor:
China Medical University Hospital
Collaborating Sponsors:
National Science and Technology Council
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 i...
Detailed Description
Bipolar I disorder (BD-I) is a severe brain disorder. At present, the treatment of BD-I, especially its depressive episode (bipolar depression), is still limited, because there is no effective treatme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05977023
Start Date
October 4 2023
End Date
December 1 2027
Last Update
February 19 2025
Active Locations (1)
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1
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan