NCT03010865

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 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 17, 2019

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

December 28, 2016

Last Update Submit

January 15, 2019

Conditions

Schizophrenic DisorderCognitive Impairment

Keywords

HDAC inhibitorsInflammation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in MATRICS Battery Score

    MATRICS Cognitive Battery

    Basline, week 6, up to 12 weeks

Secondary Outcomes (4)

  • Change from baseline in Logical Memory Test score

    Basline, up to 12 weeks

  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

    Basline, week 6, up to 12 weeks

  • Change from baseline in Paced Auditory Serial Addition Test (PASAT) score

    Basline, week 6, up to 12 weeks

  • Change from baseline in UCSD Performance-Based Skills Assessment (UPSA) total score

    Baseline, up to 12 weeks

Other Outcomes (1)

  • Change from baseline in Side-Effect Scale Score

    Basline, week 2, week 6, up to 12 weeks

Study Arms (2)

Sodium Butyrate

EXPERIMENTAL

Dietary Supplement: Sodium Butyrate 4.38 gms of sodium butyrate per day for 12 weeks

Drug: Sodium Butyrate

Placebo Oral Capsule

PLACEBO COMPARATOR

Placebo Oral Capsule placebo capsules containing approximately 9 mg of sodium butyrate per day

Drug: Placebo Oral Capsule

Interventions

Sodium ButyrateDRUG

Sodium butyrate is being supplied by T.E. Neesby (Brain White, T.E. Neesby, Inc.) in 730 mg capsules. The company asserts that their material is 98% pure and food grade. We will have identical placebo capsules. Subjects will receive 3 capsules twice daily (morning and late afternoon or evening) for a total of 4380 mg/day.

Sodium Butyrate
Placebo Oral CapsuleDRUG

Placebo Oral Capsule is also being supplied by T.E. Neesby (Brain White, T.E. Neesby, Inc.) and there is no difference from appearance, smell and taste. It contains 1.5 mg sodium butyrate per capsule. Subjects will receive 3 capsules twice daily (morning and late afternoon or evening) for a total of 9 mg/day.

Placebo Oral Capsule

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who have cognitive deficits as indicated by a score of \< 85 on RBANS,
  • meet criteria for DSM-5 diagnosis of chronic SZ, schizoaffective disorder (SA),
  • Subjects who are stably treated with antipsychotic medications and are not in acute exacerbation of illness symptoms.

You may not qualify if:

  • History of mental retardation or pervasive developmental disorder,
  • Subjects with a current serious neurological/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 medical condition,
  • Current suicidal or homicidal thoughts,
  • Current alcohol or substance abuse (other than nicotine or occasional marijuana) in the last month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

SchizophreniaCognitive DysfunctionInflammation

Interventions

Butyric Acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Chunbo Li, M.D.

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR
0

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
SPONSOR

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 5, 2017

Study Start

June 1, 2017

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

January 17, 2019

Record last verified: 2017-06

Locations

CN(1)