- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02458924
Niacin Skin Flush Response in Patients With Schizophrenia
May 30, 2015 updated by: Maryam Tabatabaeian, Isfahan University of Medical Sciences
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
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin flush response
Time Frame: 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.
|
Every 5 minutes for 20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maryam Tabatabaeian, MD, Isfahan University of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- 393230
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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