Status:
RECRUITING
Combination of NMDA-enhancing and Anti-inflammatory Treatments for Ultra-resistant Schizophrenia
Lead Sponsor:
China Medical University Hospital
Collaborating Sponsors:
National Health Research Institutes, Taiwan
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 add...
Detailed Description
Several lines of evidence suggest that both NMDA and inflammatory hypotheses have been implicated in schizophrenia. Previous study found that some NMDA-enhancing agent was able to augment efficacy of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05240976
Start Date
February 23 2022
End Date
March 1 2027
Last Update
August 26 2024
Active Locations (1)
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1
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan