Plain English Summary
Background and study aims
Skin picking disorder is a mental health condition characterized by the repetitive picking of the skin until damage is caused. It is considered to be an impulse control problem, where a patient cannot control the compulsion to pick their skin, similar to obsessive compulsive disorder (OCD). Skin picking disorder can be extremely distressing for sufferers, as the damage the condition causes to the skin can be difficult to hide and prevent them from carrying out everyday activities. Topiramate is a type of medication called an anticonvulsant, which is usually used for treating seizures. The aim of this study is to find out whether topiramate is an effective treatment for skin picking disorder.
Who can participate?
Adults who suffer from skin picking which causes significant distress.
What does the study involve?
All participants are given 25mg topiramate to take once a day for a week so that any side effects can be noted. If they do not experience any side effects, the dose is then gradually increased to 100mg twice a day. Participants in both groups are followed up every two weeks for a total of 12 weeks to see if taking the medication has reduced their skin picking, as well as to assess their general mental wellbeing.
What are the possible benefits and risks of participating?
Participants may benefit from a reduction in skin picking. Some participants mood changes, however this will be closely monitored and the doses used tightly controlled.
Where is the study run from?
Jafferany Psychiatric Services (USA)
When is the study starting and how long is it expected to run for?
June 2012 to December 2018
Who is funding the study?
Jafferany Psychiatric Services (USA)
Who is the main contact?
Dr Mohammad Jafferany
info@drjaff.com
Trial website
Contact information
Type
Public
Primary contact
Dr Mohammad Jafferany
ORCID ID
Contact details
3215 Hallmark Court
Saginaw
48603
United States of America
+1 (0)989 790 5990
info@drjaff.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Jaffpsych001
Study information
Scientific title
A pilot study of the use of topiramate in skin picking disorder
Acronym
Study hypothesis
The aim of this study is to evaluate the efficacy of topiramate in skin picking disorder.
Null hypothesis:
There is no difference in skin picking after use of topiramate.
Experimental hypothesis:
There is a difference in skin picking after use of topiramate.
Ethics approval
Ethics Committee of the Jafferany Psychiatric Services, 08/12/2013, ref: JP2013-001
Study design
Open-label flexible-dose trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Skin picking disorder
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Topiramate
Primary outcome measure
Mean time spent picking per day, measured using participant diaries at 2, 4, 6, 8 and 12 weeks
Secondary outcome measures
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
Overall trial start date
01/06/2012
Overall trial end date
29/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
01/12/2013
Recruitment end date
01/12/2017
Locations
Countries of recruitment
Pakistan, United States of America
Trial participating centre
Jafferany Psychiatric Services
3215 Hallmark Ct
Saginaw
48603
United States of America
Funders
Funder type
Hospital/treatment centre
Funder name
Jafferany Psychiatric Services
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results to be published at a later date in a medical journal within three years of study commencement while final publication is anticipated two years after final study completion.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Mohammad Jafferany MD (jaffe1m@cmich.edu)
Intention to publish date
29/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28129492