Sodium Butyrate For Improving Cognitive Function In Schizophrenia

NCT02654405 | Withdrawn Phase 2

• 1 other identifier: 809383
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HDAC inhibitors; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in MATRICS Battery Score

  MATRICS Cognitive Battery

  Baseline, week 6, up to 12 weeks

Secondary Outcomes (4)

• Change from baseline Logical Memory test score

  baseline, 12 weeks

• Change from baseline in PANSS Total Score

  baseline, 6 weeks, up to 12 weeks

• Change from baseline in PASAT Score

  baseline,6 weeks, up to 12 weeks

• change from baseline in UPSA Total score

  baseline, 12 weeks

Other Outcomes (2)

• Change from baseline in Side-Effect Scale Score

  baseline,2 weeks, 6 weeks, up to 12 weeks

• Change from baseline in clinical laboratory measures

  baseline, 12 weeks

Study Arms (2)

Sodium Butyrate

EXPERIMENTAL

6.57 gms of sodium butyrate per day for 12 weeks

Dietary Supplement: Sodium Butyrate

Placebo

PLACEBO COMPARATOR

Placebo capsule with 2 mg of sodium butyrate for making taste or odor, (9 mg/day)

Other: Placebo

Interventions

Sodium Butyrate DIETARY_SUPPLEMENT

6.57 gms of sodium butyrate per day for 12 weeks

Sodium Butyrate

Placebo OTHER

placebo capsules containing approximately 9 mg of sodium butyrate/day

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis by DSM-5 (Diagnostic Statistical Manual) diagnosis of SZ or schizoaffective disorder (SA), by consensus diagnosis using chart histories and interviews.
• Age 18-60 years of age.
• Patients will be stably treated with antipsychotic medications and are not in acute illness exacerbation of their symptoms.
• For the double-blind phase only qualification for cognitive deficits will use the following criteria:
• Subjects will have baseline MCCB battery scores which meet the following criteria. Subjects will meet the following cognitive performance criteria: a). Maximum performance level: Performance at least 1.0 standard deviation (SD) from perfect on the following three measures: Letter-number span (\< 24), Hopkins Verbal Learning Test (HVLT) total (\<31), Continuous Performance Test (CPT) d-prime (\< 3.47) and b.
• Minimum performance level: subject must be able to validly complete the baseline MATRICS assessment.

You may not qualify if:

• History of mental retardation or pervasive developmental disorder.
• Subjects with a current serious neurological/central nervous system (CNS) disorder (such as seizure disorder, stroke or multiple sclerosis) or brain trauma.
• Current treatment with valproic acid, butyrate drugs, sulforaphane, or other drugs or chemicals known to have high HDAC inhibitory activity.
• Pregnancy.
• Severe unstable current medical condition.
• Current suicidal or homicidal thoughts.
• Current alcohol or substance abuse (other than nicotine or occasional marijuana) in the last month.
• Subjects with diagnosis of congestive heart failure, or those on sodium restricted diet.

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Nathan Kline Insitute for Psychiatric Research

Orangeburg, New York, 10962, United States

Location

MeSH Terms

Conditions

Schizophrenia; Inflammation

Interventions

Butyric Acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Robert C Smith, M.D., Ph.D

  Nathan Kline Institute for Pstychiatric Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist, Research Professor of Psychiatry

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 13, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 15, 2016

Record last verified: 2016-08

Locations

US (1)