Status:
RECRUITING
Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia
Lead Sponsor:
China Medical University Hospital
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
sigma-1 receptor (S1R) agonistic property have been tested in clinical trials for the treatment of schizophrenia. In addition, previous studies found that some NMDA receptor (NMDAR)-enhancing agents w...
Detailed Description
The current treatment for schizophrenia remains unsatisfactory; thus, development of new treatments is vital. Both sigma-1 receptor (S1R) dysfunction and NMDA receptor (NMDAR) hypofunction contribute ...
Eligibility Criteria
Inclusion
- Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
- Are resistant to adequate treatments of at least two antipsychotics (excluding clozapine)
- Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 8-week trial
- PANSS total score \>70
- Hamilton Depression Rating Scale-17 items (HAMD) \<7
- Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant.
- 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, central nervous system diseases or mental disorders other than schizophrenia (including major depressive disorder, bipolar disorders, persistent depressive disorder, obsessive-compulsive disorder)
- Pregnancy or lactation
- Inability to follow protocol
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06574360
Start Date
September 23 2024
End Date
March 1 2029
Last Update
October 8 2024
Active Locations (1)
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1
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan