RecruitingPhase 2NCT04959201

Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia


Sponsor

China Medical University Hospital

Enrollment

90 participants

Start Date

Nov 30, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of schizophrenia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
  • Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial
  • PANSS total score ≥ 60
  • Agree to participate in the study and provide informed consent

Exclusion Criteria5

  • DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
  • History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study
  • Clinically significant laboratory screening tests (including blood routine, biochemical tests)
  • Pregnancy or lactation
  • Inability to follow protocol

Interventions

DRUGNMDAE plus AO

Use of an NMDA enhancer plus a drug with antioxidant property for the treatment of schizophrenia.

DRUGNMDAE plus Placebo Cap

Use of an NMDA enhancer plus placebo as a comparator.


Locations(1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

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NCT04959201


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