Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
Department of Psychiatry, China Medical University Hospital
RECRUITING
Taichung
Time Frame
Start Date: 2024-09-23
Estimated Completion Date: 2029-03
Participants
Target number of participants: 90
Treatments
Experimental: S1R agonist (S1RA) plus NMDAE
An S1R agonist plus an NMDA enhancer
Placebo_comparator: S1R agonist (S1RA) plus placebo
An S1R agonist plus placebo
Related Therapeutic Areas
Sponsors
Leads: China Medical University Hospital

This content was sourced from clinicaltrials.gov

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