The Topical Niacin Skin Flush Test in First Episode Psychosis

Schizophrenia Clinical Trial

Official title:

The Topical Niacin Skin Flush Test: A Means for Longitudinal Monitoring of Two Different Biological Subgroups of Patients With First Episode Psychosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01324297
• Other study ID #: CDHA-RS_2011-215
• Status: Terminated
• Phase: Phase 3
• First received: March 24, 2011
• Last updated: July 27, 2016
• Start date: December 2011
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 30 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Canada	Nova Scotia First Episode Psychosis Program; QEII health Sciences Centre; Capital District Health Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No