The Topical Niacin Skin Flush Test in First Episode Psychosis

NCT01324297 | Terminated

• 1 other identifier: CDHA-RS_2011-215
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders; Schizophrenia

Keywords

Diagnostic Techniques and Procedures; Sensitivity and Specificity; Skin Tests; Biological Markers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Healthy Control

Caucasian males and females between 19 and 30 years of age.

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.

Other: skin test

Interventions

skin test OTHER

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; Healthy Control

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy young adults

You may qualify if:

• caucasian
• within twelve months of initial DSM IV TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS
• outpatient

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia First Episode Psychosis Program; QEII health Sciences Centre; Capital District Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Related Publications (2)

• 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.

  PMID: 18656334 BACKGROUND

• 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.

  PMID: 20305586 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Hypersensitivity

Interventions

Skin Tests

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Phillip G Tibbo, MD, FRCPC

  Capital District Health Authority, Nova Scotia, Canada

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Neuropsychologist

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 29, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-07

Locations

CA (1)