Psychotic Disorders | The Topical Niacin Skin Flush Test in First Episode Psychosis
Psychotic Disorders research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:skin testfour 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Healthy ControlCaucasian males and females between 19 and 30 years of age.
First Episode PsychosisCaucasian 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.
Start Date: December 2011
Completed Date: July 2016
Phase: Phase 3
Primary Outcome: change in visual rating of skin response (redness and oedema)
Study sponsors, principal investigator, and references
Principal Investigator: Phillip G Tibbo, MD, FRCPC
Lead Sponsor: Nova Scotia Health Authority
Kerr M, Cotton S, Proffitt T, McConchie M, Markulev C, Smesny S, McGorry P, Berger G. The topical niacin sensitivity test: an inter- and intra-rater reliability study in healthy controls. Prostaglandins Leukot Essent Fatty Acids. 2008 Jul-Aug;79(1-2):15-9. doi: 10.1016/j.plefa.2008.06.001. Epub 2008 Jul 24.