Actively Recruiting
Sex Differences in NMDA-enhancing Treatment of Schizophrenia
Led by China Medical University Hospital · Updated on 2025-09-17
90
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
Sponsors
C
China Medical University Hospital
Lead Sponsor
N
National Science and Technology Council, Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Schizophrenia differs between sexes in clinical symptoms and functional outcome. Negative symptoms are the core pathology of this disease. NMDA receptor (NMDAR) dysfunction is a key factor in negative symptoms. This study aims to examine the sex difference in the efficacy of an NMDA-enhancer (NMDAE) for the treatment of negative symptoms in schizophrenia.
CONDITIONS
Official Title
Sex Differences in NMDA-enhancing Treatment of Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a DSM-5 diagnosis of schizophrenia
- Stable mental condition for at least 6 months before baseline with predominantly negative symptoms for 6 months or more
- Minimum baseline total score of 40 on the Scale for Assessment of Negative Symptoms
- Minimum baseline score of 24 on the negative subscale of the Positive and Negative Syndrome Scale
- Maximum score of 3 on each item of the Positive and Negative Syndrome Scale-positive subscale
- Physically healthy with clinically insignificant blood and biochemical lab tests
- Fixed dose of antipsychotics for at least 6 months with no changes allowed during the 12-week study
- Sufficient education to communicate and complete study assessments
- Agree to participate and provide written informed consent
You will not qualify if you...
- Diagnosis of intellectual disability or substance (including alcohol) use disorder
- History of epilepsy, head trauma, or serious medical or central nervous system diseases other than schizophrenia
- Clinically evident depressive symptoms or a baseline score greater than 7 on the Hamilton Depression Rating Scale-17 items
- Clinically relevant parkinsonism or baseline score greater than 3 on the first eight items of the Simpson-Angus Scale
- Pregnancy or lactation
- Inability to follow the study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
Research Team
H
Hsien-Yuan 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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