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Combination of NMDA-enhancing and Anti-inflammatory Treatments for Schizophrenia

Phase 2
Recruiting
Conditions
Schizophrenia
Registration Number
NCT04917302
Lead Sponsor
China Medical University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

Inclusion Criteria:<br><br> - Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia<br><br> - Are resistant to adequate treatments of at least two antipsychotics<br><br> - Remain symptomatic but without clinically significant fluctuation, while their<br> antipsychotic doses are unchanged for at least 3 months and will be maintained<br> during the period of the 12-week trial<br><br> - PANSS total score = 70<br><br> - Agree to participate in the study and provide informed consent<br><br>Exclusion Criteria:<br><br> - DSM-5 diagnosis of intellectual disability or substance (including alcohol) use<br> disorder<br><br> - History of epilepsy, head trauma, stroke, or serious medical or central nervous<br> system diseases (other than schizophrenia) which may interfere with the study<br><br> - Clinically significant laboratory screening tests (including blood routine,<br> biochemical tests)<br><br> - Pregnancy or lactation<br><br> - Inability to follow protocol

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change of Positive and Negative Syndrome Scale (PANSS)
Secondary Outcome Measures
NameTimeMethod
Change of scales for the Assessment of Negative Symptoms (SANS) total score;Positive subscale, Negative subscales, and General Psychopathology subscale of PANSS;Clinical Global Impression;Global Assessment of Functioning;Hamilton Rating Scale for Depression;Quality of Life Scale;Cognitive function
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