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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01324297
Other study ID # CDHA-RS_2011-215
Secondary ID
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


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
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