Back to resultsNiacin Skin Flush Response in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Niacin skin test
Sponsored by
About this trial
This is an interventional diagnostic trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Schizophrenia
Bipolar disorder
First degree relatives
Health controls
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02458924
First Posted
May 28, 2015
Last Updated
May 30, 2015
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02458924
Brief Title
Niacin Skin Flush Response in Patients With Schizophrenia
Official Title
Niacin Skin Flush Response in Patients With Schizophrenia, Their First Degree Relatives, Bipolar Disorder Patients, and Healthy Controls
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Schizophrenia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bipolar disorder
Arm Type
Active Comparator
Arm Description
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.
Arm Title
First degree relatives
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Health controls
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Niacin skin test
Other Intervention Name(s)
Methyl nicotinate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skin flush response
Description
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.
Time Frame
Every 5 minutes for 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Tabatabaeian, MD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Niacin Skin Flush Response in Patients With Schizophrenia
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