S1RA plus NMDAE: Use of an S1R agonist plus an NMDA enhancer for the treatment of treatment-resistant schizophrenia.
S1RA plus Placebo Cap: Use of an S1R agonist plus placebo as a comparator
Study 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 were able to improve clinical symptoms of patients with chronic schizophrenia. Whether combined treatment of an S1R agonist and an NMDA-enhancing agent can be better than an S1R agonist alone deserves study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Change of Positive and Negative Syndrome Scale (PANSS) — week 0, 2, 4, 6, 8 Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome.
Trial sites (1)
Facility
City
Region
Status
Department of Psychiatry, China Medical University Hospital
Taichung
Taiwan
Recruiting
More China Medical University Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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