The Topical Niacin Skin Flush Test in First Episode Psychosis

Terminated

• Conditions: Psychotic Disorders; Schizophrenia

• Registration Number: NCT01324297
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

The purpose of this study is to gather normative data from healthy adults and to determine a sensitive and specific cut-off value for responders and non-responders to the Niacin Skin Flush Test in a sample of first episode psychosis patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Study Start: 2011-12
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• caucasian
• within twelve months of initial DSM IV TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS
• outpatient

Exclusion Criteria

• known allergy to study compound (methyl nicotinate, vitamin B3, niacin)
• skin conditions (e.g., dermatitis, psoriasis, eczema)
• diagnosis or treatment for medical conditions that may affect normal vascular tone (e.g., diabetes, vasculitis, chronic hypertension, etc.)
• Use of anti-inflammatory, antibiotic, or antihistamine medications within one month prior to study entry
• Use of supplements like Omega 3 fatty acids within 3 months prior to study entry
• Use of vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 50 mg/day at study entry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in visual rating of skin response (redness and oedema)	ratings made at 3, 6, 9 and 12 minutes after application of methyl nicotinate	A 7-point visual rating scale, previously tested for reliability (Kerr 2008), to visually rate the skin response to aqueous methyl nicotinate (niacin) with respect to both redness and oedema as a function of increasing niacin concentrations.Ratings will be acquired every three minutes over a 12-minute period starting at the time of solution application.

Trial Locations

Locations (1)

Nova Scotia First Episode Psychosis Program; QEII health Sciences Centre; Capital District Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada