MedPath

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

Phase 2
Recruiting
Conditions
Schizophrenia
Registration Number
NCT05240976
Lead Sponsor
China Medical University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
80
Inclusion Criteria

Inclusion Criteria:<br><br> - Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia<br><br> - Are treatment-resistant to standard treatments of at least two specific<br> antipsychotics before clozapine treatment<br><br> - Are receiving adequate trials of clozapine for more than 12 weeks but without<br> satisfactory response<br><br> - PANSS total score = 70; SANS total score = 40<br><br> - Have sufficient education to communicate effectively and are capable of completing<br> the assessments of the study<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, or serious medical or central nervous system<br> 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 cognitive function
Secondary Outcome Measures
NameTimeMethod
Change of Positive and Negative Syndrome Scale (PANSS);Change of scale for the Assessment of Negative Symptoms (SANS) total score;Chang of positive subscale of PANSS;Change of negative subscale of PANSS;Change of general Psychopathology subscale of PANSS;Change of clinical Global Impression;Change of global Assessment of Functioning;Change of hamilton Rating Scale for Depression;Change of quality of Life Scale
© Copyright 2025. All Rights Reserved by MedPath