Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia
- Conditions
- Schizophrenia
- Registration Number
- NCT06574360
- Lead Sponsor
- China Medical University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 90
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 (excluding<br> clozapine)<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 8-week trial<br><br> - PANSS total score >70<br><br> - Hamilton Depression Rating Scale-17 items (HAMD) <7<br><br> - Are physically healthy and laboratory assessments (including blood routine,<br> biochemical tests) are clinically insignificant.<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, central nervous system diseases or mental<br> disorders other than schizophrenia (including major depressive disorder, bipolar<br> disorders, persistent depressive disorder, obsessive-compulsive disorder)<br><br> - Pregnancy or lactation<br><br> - Inability to follow protocol
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of Positive and Negative Syndrome Scale (PANSS)
- Secondary Outcome Measures
Name Time Method 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;Quality of Life Scale;Cognitive function