The Topical Niacin Skin Flush Test in First Episode Psychosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: March 5, 2014
Last verified: March 2014
  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:


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: June 2015
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 5, 2014
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 August 28, 2014