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The Topical Niacin Skin Flush Test in First Episode Psychosis

This study is currently recruiting participants.
Verified December 2011 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: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Psychotic Disorders
Schizophrenia
 Other: skin test
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Topical Niacin Skin Flush Test: A Means for Longitudinal Monitoring of Two Different Biological Subgroups of Patients With First Episode Psychosis

Resource links provided by NLM:

Drug Information available for: Niacin
U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   19 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324297

Contacts
Contact: Beverly C Butler, PhD 902-473-1062 beverly.butler@cdha.nshealth.ca

Locations
Canada, Nova Scotia
Nova Scotia First Episode Psychosis Program; QEII health Sciences Centre; Capital District Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Principal Investigator: Beverly C Butler, PhD            
Sub-Investigator: Phillip G Tibbo, MD, FRCPC            
Sub-Investigator: Heather I Milliken, MD, FRCPC            
Sub-Investigator: Kim PM Good, PhD            
Sub-Investigator: David M Gardner, PharmD, MSc            
Sub-Investigator: Denise C Bernier, PhD            
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Study Chair: Phillip G Tibbo, MD, FRCPC Capital District Health Authority, Nova Scotia, Canada
  More Information

Publications:

Responsible Party: Beverly Butler, Research Neuropsychologist, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01324297     History of Changes
Other Study ID Numbers: CDHA-RS_2011-215
Study First Received: March 24, 2011
Last Updated: December 20, 2011
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Diagnostic Techniques and Procedures
Sensitivity and Specificity
Skin Tests
Biological Markers

Additional relevant MeSH terms:
Flushing
Psychotic Disorders
Mental Disorders
 Schizophrenia
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 19, 2013