The Topical Niacin Skin Flush Test in First Episode Psychosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Beverly Butler, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01324297
First received: March 24, 2011
Last updated: February 11, 2015
Last verified: February 2015

March 24, 2011
February 11, 2015
December 2011
June 2015   (final data collection date for primary outcome measure)
change in visual rating of skin response (redness and oedema) [ Time Frame: ratings made at 3, 6, 9 and 12 minutes after application of methyl nicotinate ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01324297 on ClinicalTrials.gov Archive Site
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The Topical Niacin Skin Flush Test in First Episode Psychosis
The Topical Niacin Skin Flush Test: A Means for Longitudinal Monitoring of Two Different Biological Subgroups of Patients With First Episode Psychosis

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Healthy young adults

  • Psychotic Disorders
  • Schizophrenia
Other: skin test
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.
  • Healthy Control
    Caucasian males and females between 19 and 30 years of age.
    Intervention: Other: skin test
  • First Episode Psychosis
    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.
    Intervention: Other: skin test

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
19 Years to 30 Years
Yes
Contact: Beverly C Butler, PhD 902-473-1062 beverly.butler@cdha.nshealth.ca
Canada
 
NCT01324297
CDHA-RS_2011-215
No
Beverly Butler, Capital District Health Authority, Canada
Capital District Health Authority, Canada
Not Provided
Study Chair: Phillip G Tibbo, MD, FRCPC Capital District Health Authority, Nova Scotia, Canada
Capital District Health Authority, Canada
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP