NCT05240976 Combination of NMDA-enhancing and Anti-inflammatory Treatments for Ultra-resistant Schizophrenia
| NCT ID | NCT05240976 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | China Medical University Hospital |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-02-23 |
| Primary Completion | 2027-02 |
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 80 participants in total. It began in 2022-02-23 with a primary completion date of 2027-02.
⚠ 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 study found that some NMDA-enhancing agent was able to augment efficacy of clozapine for clinical symptoms but not cognitive function in the treatment of ultra-resistant schizophrenia. In addition, several drugs with anti-inflammatory properties have been tested in clinical trials for the treatment of schizophrenia. Whether a drug with anti-inflammatory property can strengthen the efficacy of an NMDA-enhancer (NMDAE) in the treatment of ultra-resistant schizophrenia remains unknown.
Eligibility Criteria
Inclusion Criteria: * Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia * Are treatment-resistant to standard treatments of at least two specific antipsychotics before clozapine treatment * Are receiving adequate trials of clozapine for more than 12 weeks but without satisfactory response * PANSS total score ≥ 70; SANS total score ≥ 40 * Have sufficient education to communicate effectively and are capable of completing the assessments of the study * Agree to participate in the study and provide 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 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 NCT05240976 clinical trial?
This trial is open to participants of all sexes, aged 18 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 NCT05240976 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 NCT05240976 currently recruiting?
Yes, NCT05240976 is actively recruiting participants. Contact the research team at hylane@gmail.com for enrollment information.
Where is the NCT05240976 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT05240976 clinical trial?
NCT05240976 is sponsored by China Medical University Hospital. The trial plans to enroll 80 participants.
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