Niacin Skin Flush Response in Patients With Schizophrenia

Niacin Skin Flush Response in Patients With Schizophrenia, Their First Degree Relatives, Bipolar Disorder Patients, and Healthy Controls

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Biological: Niacin skin test

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Schizophrenia; 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.	Biological: Niacin skin test; Two concentrations including 0.5 ml solutions of 0.01 M and 0.1 M diluted methyl nicotinate were applied for one minute to the inside of the different forearms of each individual.; Other Names: Methyl nicotinate
Active Comparator: Bipolar disorder; 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.	Biological: Niacin skin test; Two concentrations including 0.5 ml solutions of 0.01 M and 0.1 M diluted methyl nicotinate were applied for one minute to the inside of the different forearms of each individual.; Other Names: Methyl nicotinate
Active Comparator: First degree relatives; 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.	Biological: Niacin skin test; Two concentrations including 0.5 ml solutions of 0.01 M and 0.1 M diluted methyl nicotinate were applied for one minute to the inside of the different forearms of each individual.; Other Names: Methyl nicotinate
Active Comparator: Health controls; 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.	Biological: Niacin skin test; Two concentrations including 0.5 ml solutions of 0.01 M and 0.1 M diluted methyl nicotinate were applied for one minute to the inside of the different forearms of each individual.; Other Names: Methyl nicotinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin flush response	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.	Every 5 minutes for 20 minutes

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Principal Investigator: Maryam Tabatabaeian, MD, Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): June 1, 2015

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 30, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Niacin
• Other Study ID Numbers: 393230