Niacin Skin Flush Response in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458924
• Other study ID #: 393230
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 28, 2015
• Last updated: May 30, 2015
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No