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Sodium Butyrate For Improving Cognitive Function In Schizophrenia

NCT02654405 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2016-08-15

No results posted yet for this study

Summary

The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel treatment for cognitive deficits in schizophrenia (SZ).

The proposal consists of a small preliminary open label study to assess tolerability and side effects of sodium butyrate in schizophrenic patients receiving antipsychotic treatment, followed by a larger double-blind study of the effects of sodium butyrate on cognitive function and symptoms in SZ patients who are not in an acute exacerbation of the primary symptoms and show continued cognitive deficits. Secondary aims will be to evaluate its effects on improving symptoms and functioning in SZ, and the relationship of the drug's clinical effects to epigenetic and inflammation related biochemical changes.

Conditions

  • Schizophrenic Disorders
  • Cognitive Function

Interventions

DIETARY_SUPPLEMENT

Sodium Butyrate

6.57 gms of sodium butyrate per day for 12 weeks

OTHER

Placebo

placebo capsules containing approximately 9 mg of sodium butyrate/day

Sponsors & Collaborators

  • Stanley Medical Research Institute

    collaborator OTHER

  • Nathan Kline Institute for Psychiatric Research

    lead OTHER

Principal Investigators

  • Robert C Smith, M.D., Ph.D · Nathan Kline Institute for Pstychiatric Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02654405 on ClinicalTrials.gov