NCT05052853 Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
| NCT ID | NCT05052853 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | China Medical University Hospital |
| Condition | Prodromal Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2026-10 |
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 48 participants in total. It began in 2021-11-01 with a primary completion date of 2026-10.
⚠ 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
Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. Whether treatment of an NMDA-enhancing agent can benefit the treatment of prodromal schizophrenia deserves study.
Eligibility Criteria
Inclusion Criteria: * Individuals meeting Criteria of Prodromal Syndrome (at least one of the following: 1. attenuated positive symptoms; 2. brief intermittent psychotic symptoms; 3. genetic risk and deterioration). * Subjects remain symptomatic (scoring at least 20 on the Scale of Prodromal Symptoms \[SOPS\] total score) after the 6-week screening phase (which contains the health-promotion program) and before the 12-week drug-trial period. * Subjects may be receiving ongoing treatment with antipsychotic medications, or may be medication-free for at least 12 weeks.For the subjects who have already been on such medications, the medications need to be continued for at least 4 weeks before the screening phase and the doses need to be kept unchanged during the study period. For those who have not yet been on such medications, these medications are forbidden during the study period. * Subjects agree to participate in the study and provide written informed consent after complete description of the study. For the subject \< 20 years old, a parent also has to provide written informed consent. Exclusion Criteria: * DSM-5 diagnosis of intellectual disability, substance (including alcohol) use disorder, schizophrenia, schizophreniform disorder, delusional disorder, schizoaffective disorder, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition. * History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study. * Clinically significant laboratory screening tests (including blood routine, biochemical tests) * Pregnancy or lactation * Inability to follow protocol
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05052853 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 45 Years, studying Prodromal 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 NCT05052853 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 NCT05052853 currently recruiting?
Yes, NCT05052853 is actively recruiting participants. Contact the research team at hylane@gmail.com for enrollment information.
Where is the NCT05052853 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT05052853 clinical trial?
NCT05052853 is sponsored by China Medical University Hospital. The trial plans to enroll 48 participants.
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