Status:
RECRUITING
NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia
Lead Sponsor:
China Medical University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Cognitive impairment, the core psychopathology of schizophrenia, usually persists in schizophrenia patients even during symptomatic remission. While cognitive impairment associated with schizophrenia ...
Detailed Description
Cognitive impairment, the core psychopathology and the outcome determinant of schizophrenia, usually persists in schizophrenia patients even during symptomatic remission. Cognitive impairment associat...
Eligibility Criteria
Inclusion
- Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5 -TR) diagnosis of schizophrenia
- Fulfill the Remission in Schizophrenia Working Group (RSWG) criteria for remission (Andreasen et al., 2005): each of eight items (delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, passive/apathetic social withdrawal, and lack of spontaneity and flow of conversation) in the Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1987) scoring 3 or lower for 6 months or longer; in addition, have a baseline total score of 59 or lower in the PANSS
- Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;
- Have been keeping a fixed dose of antipsychotics (excluding clozapine) 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
- DSM-5-TR 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
- Pregnancy or lactation
- Inability to follow protocol
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06021197
Start Date
October 12 2023
End Date
March 1 2028
Last Update
February 19 2025
Active Locations (1)
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1
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan