The Topical Niacin Skin Flush Test in First Episode Psychosis

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01324297

Enrollment

107

Registered

2011-03-29

Start date

2011-12-31

Completion date

2016-07-31

Last updated

2016-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorders, Schizophrenia

Keywords

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

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.

Interventions

OTHERskin 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 30 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
change in visual rating of skin response (redness and oedema)	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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026