Niacin Skin Flush Response in Patients With Schizophrenia

NCT ID: NCT02458924

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Niacin skin test

Intervention Type BIOLOGICAL

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.

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.

Group Type ACTIVE_COMPARATOR

Niacin skin test

Intervention Type BIOLOGICAL

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.

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.

Group Type ACTIVE_COMPARATOR

Niacin skin test

Intervention Type BIOLOGICAL

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.

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.

Group Type ACTIVE_COMPARATOR

Niacin skin test

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Methyl nicotinate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Maryam Tabatabaeian

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maryam Tabatabaeian, MD

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Other Identifiers

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393230

Identifier Type: -

Identifier Source: org_study_id

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