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Clinical Trials in Taiwan / NCT04745143
Recruiting Phase 2

Monotherapy of an NMDA Enhancer for Schizophrenia

NCT04745143 · tracked via the Priya Life Science Taiwan tracker
Sponsor
China Medical University Hospital
Phase
Phase 2
Started
2018-01-01
Last updated
2026-03-24

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

NMDAE →Placebo Cap

NMDAE: Use of an NMDA enhancer for the treatment of schizophrenia

Placebo Cap: Use of placebo as a comparator

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia * Refuse or are unable to tolerate antipsychotics due to poor response or adverse effects * PANSS total score ≥ 60 * Free of antipsychotic drugs for at least 1 week * Agree to participate in the study and provide informed consent Exclusion Criteria: * Current substance abuse or history of substance dependence in the past 3 months * History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study * Use of depot antipsychotic in the past 3 months; * Clinically significant laboratory screening tests * Pregnancy or lactation * Inability to follow protocol

Primary outcome measure(s)

  • Change of Positive and Negative Syndrome Scale (PANSS) — week 0, 2, 4, 6
    Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome.
  • Change of scales for the Assessment of Negative Symptoms (SANS) total score — week 0, 2, 4, 6
    Assessment of negative symptoms. Minimum value: 0, maximum value:100, the higher scores mean a worse outcome.

Trial sites (1)

FacilityCityRegionStatus
Department of Psychiatry, China Medical University Hospital Taichung Taiwan Recruiting

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Other trials for the same condition

A Study of Brenipatide in Adult Participants With Schizophrenia Recruiting
Combination of NMDA-enhancing and Anti-inflammatory Treatments for Ultra-resistant Schizophrenia Recruiting
Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia Recruiting
NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia Recruiting
A Computational Neuroscience Perspective on the Shared Social Cognitive Deficits of Autism and Schizophrenia Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04745143 on ClinicalTrials.gov ↗ ← All trials in Taiwan