Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT04745143

Monotherapy of an NMDA Enhancer for Schizophrenia

Led by China Medical University Hospital · Updated on 2026-03-24

80

Participants Needed

1

Research Sites

517 weeks

Total Duration

On this page

Sponsors

C

China Medical University Hospital

Lead Sponsor

N

National Health Research Institutes, Taiwan

Collaborating Sponsor

AI-Summary

What this Trial Is About

Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing clinical symptoms and cognitive deficits and revealed favorable safety in patients with chronic schizophrenia. Of note, a substantial portion of schizophrenia patients refuse or cannot tolerate antipsychotics due to poor response or severe side effects. Therefore, this study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) as a monotherapy for the treatment of schizophrenia.

CONDITIONS

Official Title

Monotherapy of an NMDA Enhancer for Schizophrenia

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a DSM-5 diagnosis of schizophrenia
  • Refuse or are unable to tolerate antipsychotics due to poor response or adverse effects
  • PANSS total score of 60 or higher
  • Free of antipsychotic drugs for at least 1 week
  • Agree to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Current substance abuse or substance dependence in the past 3 months
  • History of epilepsy, head trauma, stroke, or other serious medical or neurological illness
  • Use of depot antipsychotic in the past 3 months
  • Clinically significant abnormal laboratory screening tests
  • Pregnancy or breastfeeding
  • Inability to follow the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

Actively Recruiting

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Research Team

H

Hsien-Yuan Lane, M.D., Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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