The Topical Niacin Skin Flush Test in First Episode Psychosis

Study Overview
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Brief Summary
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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.

Official Title
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The Topical Niacin Skin Flush Test: A Means for Longitudinal Monitoring of Two Different Biological Subgroups of Patients With First Episode Psychosis

Conditions
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Psychotic Disorders, Schizophrenia

Intervention / Treatment
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* Other: skin test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Control<br>Caucasian males and females between 19 and 30 years of age. | Other: skin test<br>* four patches of 2 x 3cm thin blotting paper will be soaked with an equivalent amount (0.1 mL) of aqueous methyl nicotinate in four different concentrations: 0.1, 0.01, 0.001, 0.0001 M. The four patches will then be applied at the same time to the inner forearm for 60 seconds.<br>|
| First Episode Psychosis<br>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. | Other: skin test<br>* four patches of 2 x 3cm thin blotting paper will be soaked with an equivalent amount (0.1 mL) of aqueous methyl nicotinate in four different concentrations: 0.1, 0.01, 0.001, 0.0001 M. The four patches will then be applied at the same time to the inner forearm for 60 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in visual rating of skin response (redness and oedema) | 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. | ratings made at 3, 6, 9 and 12 minutes after application of methyl nicotinate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic Techniques and Procedures, Sensitivity and Specificity, Skin Tests, Biological Markers