RecruitingPhase 2NCT04917302

Combination of NMDA-enhancing and Anti-inflammatory Treatments for Schizophrenia


Sponsor

China Medical University Hospital

Enrollment

60 participants

Start Date

Oct 13, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with chronic schizophrenia. In addition, several drugs with anti-inflammatory 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 anti-inflammatory property can be better than an NMDA-enhancing agent alone deserves study.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
  • Are resistant to adequate treatments of at least two antipsychotics
  • 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 ≥ 70
  • 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 AIFA

Use of an NMDA enhancer plus a drug with anti-inflammatory 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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NCT04917302


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