Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06021197

NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia

Led by China Medical University Hospital · Updated on 2025-02-19

90

Participants Needed

1

Research Sites

228 weeks

Total Duration

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Sponsors

C

China Medical University Hospital

Lead Sponsor

N

National Science and Technology Council, Taiwan

Collaborating Sponsor

AI-Summary

What this Trial Is About

Cognitive impairment, the core psychopathology of schizophrenia, usually persists in schizophrenia patients even during symptomatic remission. While cognitive impairment associated with schizophrenia (CIAS) is an important therapeutic target, hypofunction of N-methyl-D-aspartate receptor (NMDAR) is a key factor of CIAS. This study aims to examine the efficacy and safety of an NMDA-enhancer (NMDAE) for the treatment of CIAS in schizophrenia patients during symptomatic remission.

CONDITIONS

Official Title

NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5 -TR) diagnosis of schizophrenia
  • Fulfill the Remission in Schizophrenia Working Group (RSWG) criteria for remission: each of eight items in the Positive and Negative Syndrome Scale (PANSS) scoring 3 or lower for 6 months or longer; baseline total PANSS score 59 or lower
  • Are physically healthy and laboratory assessments are clinically insignificant
  • Have been keeping a fixed dose of antipsychotics (excluding clozapine) for at least 6 months, with no changes allowed during the 12-week study
  • Have sufficient education to communicate effectively and complete study assessments
  • Agree to participate and provide written informed consent
Not Eligible

You will not qualify if you...

  • DSM-5-TR diagnosis of intellectual disability or substance (including alcohol) use disorder
  • History of epilepsy, head trauma, or serious medical or central nervous system diseases (other than schizophrenia) interfering with the study
  • Pregnancy or lactation
  • Inability to follow 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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