NCT05052853

Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. Whether treatment of an NMDA-enhancing agent can benefit the treatment of prodromal schizophrenia deserves study.

Detailed description

Several lines of evidence suggest that NMDA hypotheses have been implicated in schizophrenia. Previous studies found that some NMDA-enhancing agents were able to benefit the treatment of schizophrenia. Whether an NMDA-enhancer (NMDAE) can benefit the treatment of prodromal schizophrenia deserves study. Therefore, this study aims to compare NMDAE and placebo in the treatment of prodromal schizophrenia. The subjects with prodromal schizophrenia at first receive 6 weeks of health-promotion intervention (including exercise and education). A total of 48 subjects who do not respond sufficiently to the health-promotion program are then recruited to this 12-week, randomized, double-blind, placebo-controlled trial, which aims to compare treatment response of NMDAE vs. placebo in 1:1 ratio. Clinical performances and side effects are measured at weeks -6 (before the screening phase), 0 (baseline of the drug trial), 2, 4, 6, 9, and 12. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests. The efficacies of NMDAE and placebo will be compared. Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.

Conditions

• Prodromal Schizophrenia

Interventions

Type	Name	Description
DRUG	NMDAE	Use of an NMDA enhancer for the treatment of prodromal schizophrenia .
DRUG	Placebo Cap	Use of placebo as a comparator

Timeline

• Start date: 2021-11-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2021-09-22
• Last updated: 2026-03-24

Locations

1 site across 1 country: Taiwan