The Topical Niacin Skin Flush Test in First Episode Psychosis

Terminated

• Conditions: Psychotic Disorders; Schizophrenia
• Interventions: Other: skin test

• 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

Arm && Interventions

Group	Intervention	Description
Healthy Control	skin test	Caucasian males and females between 19 and 30 years of age.
First Episode Psychosis	skin test	Caucasian males and females between 19 and 30 years of age within twelve months of initial DSM IV TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS.

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