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Niacin Skin Flush Response in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT02458924
Recruitment Status : Completed
First Posted : June 1, 2015
Last Update Posted : June 2, 2015
Sponsor:
Information provided by (Responsible Party):
Maryam Tabatabaeian, 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Biological: Niacin skin test Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Niacin Skin Flush Response in Patients With Schizophrenia, Their First Degree Relatives, Bipolar Disorder Patients, and Healthy Controls
Study Start Date : January 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014


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 Name: 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 Name: 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 Name: 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 Name: Methyl nicotinate




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458924


Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Principal Investigator: Maryam Tabatabaeian, MD Isfahan University of Medical Sciences
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Responsible Party: Maryam Tabatabaeian, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02458924    
Other Study ID Numbers: 393230
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Niacin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs