Sex Differences in NMDA-enhancing Treatment of Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 65
Healthy Volunteers: f
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• Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia

• keep stable mentally for ≥ 6 months before baseline and meet the following clinical criteria: predominantly negative symptoms for ≥ 6 months, a minimum baseline total score of 40 on the SANS, a minimum baseline score of 24 on the negative subscale of the PANSS, and a maximum score of 3 on each item of PANSS-positive subscale;

• Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;

• Have been keeping a fixed dose of antipsychotics for at least 6 months, and that is not allowed to change during the 12-week study period

• Have sufficient education to communicate effectively and are capable of completing the assessments of the study

• Agree to participate in the study and provide written informed consent

Locations
Other Locations
Taiwan
Department of Psychiatry, China Medical University Hospital
RECRUITING
Taichung
Contact Information
Primary
Hsien-Yuan Lane, M.D., Ph.D
hylane@gmail.com
886 4 22052121
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2030-03
Participants
Target number of participants: 90
Treatments
Experimental: NMDAE
An NMDA enhancer
Placebo_comparator: Placebo
Placebo
Related Therapeutic Areas
Sponsors
Collaborators: National Science and Technology Council, Taiwan
Leads: China Medical University Hospital

This content was sourced from clinicaltrials.gov

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