RecruitingPhase 2NCT04745143

Monotherapy of an NMDA Enhancer for Schizophrenia


Sponsor

China Medical University Hospital

Enrollment

80 participants

Start Date

Jan 1, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

Interventions

DRUGNMDAE

Use of an NMDA enhancer for the treatment of schizophrenia

DRUGPlacebo Cap

Use of placebo as a comparator


Locations(1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

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NCT04745143


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