Niacin Skin Flush Response in Patients With Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Biological: Niacin skin test

• Registration Number: NCT02458924
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

Patients with schizophrenia have abnormal skin flush response to niacin, but the niacin skin test accuracy is not well studied in these patients. The study evaluated the niacin skin test accuracy in adult hospitalized schizophrenia patients and their first degree relatives, bipolar disorder patients, and healthy controls.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-05
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-28
• Last Update Submitted: 2015-05-30
• Study First Posted: 2015-06-01
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosis of schizophrenia patients and bipolar disorder patients diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders version IV criteria
• Normal healthy subjects without a psychiatric history
• First degree relatives of schizophrenic patients

Exclusion Criteria

• Dermatological lesions, asthma or allergic disease, diabetes, chronic hypertension, vasculitis, substance use disorders (except cigarette smoking), or pregnancy
• Taking any oral medication that could affect the metabolism of prostaglandins such as nonsteroidal anti-inflammatory drugs or corticosteroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Schizophrenia	Niacin skin test	Skin niacin test was performed by two concentrations including 0.5 ml solutions of 0.01 M and 0.1 M diluted methyl nicotinate. The two solutions were applied for one minute to the inside of the different forearms of each individual.
Bipolar disorder	Niacin skin test	Skin niacin test was performed by two concentrations including 0.5 ml solutions of 0.01 M and 0.1 M diluted methyl nicotinate. The two solutions were applied for one minute to the inside of the different forearms of each individual.
First degree relatives	Niacin skin test	Skin niacin test was performed by two concentrations including 0.5 ml solutions of 0.01 M and 0.1 M diluted methyl nicotinate. The two solutions were applied for one minute to the inside of the different forearms of each individual.
Health controls	Niacin skin test	Skin niacin test was performed by two concentrations including 0.5 ml solutions of 0.01 M and 0.1 M diluted methyl nicotinate. The two solutions were applied for one minute to the inside of the different forearms of each individual.

Primary Outcome Measures

Name	Time	Method
Skin flush response	Every 5 minutes for 20 minutes	Skin response was assessed by a single physician every 5 minutes for 20 minutes after removal of the substance. The outcome assessor was not blinded to the applied solution dosages. The strength of the flushing reaction was classified as 0 = no redness, 1 = faint redness, 2 = distinct redness, and 3 = extreme or maximum redness.