Condition category
Mental and Behavioural Disorders
Date applied
14/12/2016
Date assigned
23/12/2016
Last edited
30/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

Sponsor information

Organisation

Jafferany Psychiatric Services

Sponsor details

3215 Hallmark Court
Saginaw
48603
United States of America

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28129492

Publication citations

Additional files

Editorial Notes

30/01/2017: Publication reference added.