Status:
RECRUITING
Combination of NMDA-enhancing and Anti-inflammatory Treatments for Schizophrenia
Lead Sponsor:
China Medical University Hospital
Collaborating Sponsors:
Ministry of Science and Technology, Taiwan
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with chronic schizophrenia. In addition, several drugs with anti-inflammatory properties have ...
Detailed Description
Several lines of evidence suggest that both NMDA and inflammatory hypotheses have been implicated in schizophrenia. Previous studies found that some NMDA-enhancing agents were able to augment efficacy...
Eligibility Criteria
Inclusion
- Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
- Are resistant to adequate treatments of at least two antipsychotics
- Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial
- PANSS total score ≥ 70
- Agree to participate in the study and provide informed consent
Exclusion
- DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
- 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
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04917302
Start Date
October 13 2020
End Date
December 1 2026
Last Update
February 19 2025
Active Locations (1)
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1
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan