Actively Recruiting
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
Led by China Medical University Hospital · Updated on 2025-02-19
90
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
C
China Medical University Hospital
Lead Sponsor
N
National Science and Technology Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NMDA Receptor Modulation for the Treatment of Bipolar I Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 65 years old
- Have a diagnosis of Bipolar I Disorder, current depressive episode, based on DSM-5-TR criteria
- Have been treated with stable antipsychotic (quetiapine or lurasidone) and/or mood stabilizer for at least 4 weeks
- Have a 17-item Hamilton Depression Rating Scale score of 18 or higher at baseline
- Have a Young Mania Rating Scale score of 7 or lower at baseline
- Agree to participate and provide informed consent
You will not qualify if you...
- Current substance abuse or substance dependence in the past 6 months
- History of epilepsy, head trauma, stroke, or other serious medical or neurological illness interfering with the study
- Diagnosis of schizophrenia or other psychotic disorders
- Moderate to severe suicidal risk
- Severe cognitive impairment
- Abnormal clinically significant laboratory test results
- Pregnancy or breastfeeding
- Inability to follow the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
Research Team
H
Hsien-Yuan Lane Lane, M.D., Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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