Schizophrenia Clinical Trial
Official title:
The Topical Niacin Skin Flush Test: A Means for Longitudinal Monitoring of Two Different Biological Subgroups of Patients With First Episode Psychosis
Verified date | July 2016 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 107 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 30 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Nova Scotia First Episode Psychosis Program; QEII health Sciences Centre; Capital District Health Authority | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority |
Canada,
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. — View Citation
Nadalin S, Buretic-Tomljanovic A, Rubesa G, Tomljanovic D, Gudelj L. Niacin skin flush test: a research tool for studying schizophrenia. Psychiatr Danub. 2010 Mar;22(1):14-27. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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