The Topical Niacin Skin Flush Test in First Episode Psychosis

NCT ID: NCT01324297

Last Updated: 2016-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psychotic Disorders Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Control

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

skin test

Intervention Type 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

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.

skin test

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Beverly Butler

Research Neuropsychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Phillip G Tibbo, MD, FRCPC

Role: STUDY_CHAIR

Capital District Health Authority, Nova Scotia, Canada

Locations

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

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 18656334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20305586 (View on PubMed)

Other Identifiers

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CDHA-RS_2011-215

Identifier Type: -

Identifier Source: org_study_id

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