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

NCT06574360 | Recruiting Phase 2 DMC

• 1 other identifier: CMUH112-REC3-202
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Schizophrenia

Keywords

Schizophrenia; NMDA; sigma-1 receptor

Outcome Measures

Primary Outcomes (1)

• Change of Positive and Negative Syndrome Scale (PANSS)

  Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome.

  week 0, 2, 4, 6, 8

Secondary Outcomes (6)

• Change of scales for the Assessment of Negative Symptoms (SANS) total score

  week 0, 2, 4, 6, 8

• Positive subscale, Negative subscales, and General Psychopathology subscale of PANSS

  week 0, 2, 4, 6, 8

• Clinical Global Impression

  week 0, 2, 4, 6, 8

• Global Assessment of Functioning

  week 0, 2, 4, 6, 8

• Quality of Life Scale

  week 0, 2, 4, 6, 8

Study Arms (2)

S1R agonist (S1RA) plus NMDAE

EXPERIMENTAL

An S1R agonist plus an NMDA enhancer

Drug: S1RA plus NMDAE

S1R agonist (S1RA) plus placebo

PLACEBO COMPARATOR

An S1R agonist plus placebo

Drug: S1RA plus Placebo Cap

Interventions

S1RA plus NMDAE DRUG

Use of an S1R agonist plus an NMDA enhancer for the treatment of treatment-resistant schizophrenia.

S1R agonist (S1RA) plus NMDAE

S1RA plus Placebo Cap DRUG

Use of an S1R agonist plus placebo as a comparator

S1R agonist (S1RA) plus placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 27, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

TW (1)