NCT07122895 Sex Differences in NMDA-enhancing Treatment of Schizophrenia
| NCT ID | NCT07122895 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | China Medical University Hospital |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-09-16 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * DSM-5 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) which may interfere with the study * Clinically evident depressive symptoms or a baseline score\>7 on the Hamilton Depression Rating Scale-17 items * Clinically relevant parkinsonism or a baseline score \>3 on the sum of the first eight items of the Simpson-Angus Scale (SAS) * Pregnancy or lactation * Inability to follow protocol
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07122895 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07122895 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07122895 currently recruiting?
Yes, NCT07122895 is actively recruiting participants. Contact the research team at hylane@gmail.com for enrollment information.
Where is the NCT07122895 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT07122895 clinical trial?
NCT07122895 is sponsored by China Medical University Hospital. The trial plans to enroll 90 participants.
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