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The Topical Niacin Skin Flush Test in First Episode Psychosis

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ClinicalTrials.gov Identifier: NCT01324297
Recruitment Status : Terminated (Unable to secure funding for second phase of study (i.e., niacin skin flush test in early psychosis patients).)
First Posted : March 29, 2011
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Beverly Butler, Nova Scotia Health Authority

Brief Summary:
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 or disease Intervention/treatment
Psychotic Disorders Schizophrenia Other: skin test

Study Type : Observational
Actual Enrollment : 107 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Topical Niacin Skin Flush Test: A Means for Longitudinal Monitoring of Two Different Biological Subgroups of Patients With First Episode Psychosis
Study Start Date : December 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
Healthy Control
Caucasian males and females between 19 and 30 years of age.
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.
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.
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.



Primary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy young adults
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324297


Locations
Canada, Nova Scotia
Nova Scotia First Episode Psychosis Program; QEII health Sciences Centre; Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 2E2
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Study Chair: Phillip G Tibbo, MD, FRCPC Capital District Health Authority, Nova Scotia, Canada

Publications:
Responsible Party: Beverly Butler, Research Neuropsychologist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01324297     History of Changes
Other Study ID Numbers: CDHA-RS_2011-215
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Keywords provided by Beverly Butler, Nova Scotia Health Authority:
Diagnostic Techniques and Procedures
Sensitivity and Specificity
Skin Tests
Biological Markers

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Niacin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs