Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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20 February 2017 |
Main ID: |
ISRCTN15791118 |
Date of registration:
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23/12/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Topiramate in skin picking disorder
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Scientific title:
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A pilot study of the use of topiramate in skin picking disorder |
Date of first enrolment:
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01/12/2013 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN15791118 |
Study type:
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Interventional |
Study design:
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Open-label flexible-dose trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Pakistan
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United States of America
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Contacts
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Name:
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Mohammad
Jafferany |
Address:
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3215 Hallmark Court
48603
Saginaw
United States of America |
Telephone:
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+1 (0)989 790 5990 |
Email:
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info@drjaff.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Recurrent skin picking resulting in skin lesions 2. Repeated attempts to decrease or stop skin picking 3. The skin picking causes clinically significant distress or impairment in social, occupational, or other important areas of functioning 4. The skin picking is not attributable to the physiological effects of a substance/another medical condition 5. The skin picking is not better explained by symptoms of another mental disorder 6. Age 18-60 years
Exclusion criteria: 1. Chronic unstable medical illness 2. Pregnancy or lactation 3. Being on other psychotropic medications 4. Current substance abuse 5. Psychotherapy in the last six weeks prior to commencing the study
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Skin picking disorder Mental and Behavioural Disorders
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Intervention(s)
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Patients with skin picking will be enrolled in the study based upon diagnostic criteria by DSM 5 and followed for a 12-week period in an open label method. Patients will be started on 25mg topiramate once a day for during the first week. Monitoring of side effects will be done during this first week and if a patient tolerated the medication, the dose of topiramate will be increased to 25mg twice a day during the second week. Next month the dose will be increased to 50mg twice a day and third month 100mg twice a day. If the desired effect was obtained at a lower dose, such dose will be maintained. They will be seen weekly for two weeks and every two weeks for the remainder of the 12 weeks open label study. Adjusting the dose of their topiramate as clinically indicated will be the main intervention that patients are exposed to.
Patients will be followed up at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks. Primary outcome measure that will be assessed include the mean time spent picking per day as each participant will be asked to keep a diary of time spent picking each day. Secondary outcomes will be evaluated using SPS-Y-BCOS, skin picking scale, Beck anxiety inventory, Beck depression inventory, CGI-severity and CGI-improvement.
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Primary Outcome(s)
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Mean time spent picking per day, measured using participant diaries at 2, 4, 6, 8 and 12 weeks
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Secondary Outcome(s)
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1. Skin picking, obsessions and compulsions are measured using SPS-Y-BCOS at 2, 4, 6, 8 and 12 weeks 2. Skin picking frequency is measured using the skin picking scale at 2, 4, 6, 8 and 12 weeks 3. Anxiety is measured using the Beck anxiety inventory at 2, 4, 6, 8 and 12 weeks 4. Depression is measured using the Beck depression inventory at 2, 4, 6, 8 and 12 weeks 5. Severity is measured using the CGI-severity at 2, 4, 6, 8 and 12 weeks 6. Improvement in clinical condition is measured using the CGI-improvement at 2, 4, 6, 8 and 12 weeks
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Secondary ID(s)
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Jaffpsych001
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Source(s) of Monetary Support
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Jafferany Psychiatric Services
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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