Escitalopram for the Treatment of Self-Injurious Skin Picking

May 19, 2008 updated by: Massachusetts General Hospital
The purpose of this study is to determine the effectiveness of escitalopram in treating self-injurious skin picking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: Self-injurious skin picking is a problem documented to occur in 2 % of dermatology patients (Gupta, Gupta and Haberman, 1986) , and approximately 4% of the general population (Keuthen et al., 2000). It is widely under recognized, with medical sequelae that can include scarring, infections, lesions, and potentially life-threatening outcomes (O'Sullivan et al., 1999). In a prior study, fluoxetine was shown to be superior to placebo in treating self-injurious skin picking in a modest-sized double blind trial (Simeon et al., 1997). Similarly, open-label trials of other SSRIs, including sertraline (Kalivas, Kalivas and Gilman, 1996) and fluvoxamine (Arnold et al., 1999) resulted in reductions in skin-picking behavior. Escitalopram is a new SSRI that may have superior efficacy for the treatment of major depression and fewer side effects than other SSRIs. This study aims to assess the efficacy of escitalopram in patients who suffer from self-injurious skin-picking.

Comparisons: Subjects' initial scores on the CGI, HAM-D, SPTS, SPS, SPIS, BDI, BAI, QLESQ, & BDDQ will be compared to subjects' final scores.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Repetitive skin picking resulting in noticeable tissue damage and associated emotional distress and/or functional impairment.
  • Age 18-65 years old.
  • Duration of skin picking symptoms ≥ 6 months.
  • MGH Skin Picking Scale score ≥ 10.
  • Written informed consent.
  • Females of childbearing potential must have a negative serum or urinary beta-HCG test and be willing to use acceptable methods of birth control during study tenure.

Exclusion Criteria:

  • Pregnant women or females of childbearing potential who do not consent to use of a medically acceptable method of contraception.
  • Women who are breastfeeding.
  • Subjects who pose a serious suicidal or homicidal risk in the judgment of study investigators.
  • Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease.
  • Subjects with a dermatologic disorder that causes pruritis.
  • Patients on anticoagulant therapy.
  • History of seizure disorder.
  • Comorbid bipolar disorder, psychosis, organic mental disorder, borderline personality disorder or developmental disorder. Subjects with obsessive compulsive disorder (with primary symptoms other than compulsive skin picking).
  • History of substance dependence. If there is a history of substance abuse, subjects should be in remission for ≥ 6 months.
  • Current treatment with cognitive behavioral therapy for skin picking.
  • Current use of another SSRI medication.
  • Other medications for medical disorders that might interfere with escitalopram.
  • Current major depression or prescribed an antidepressant for major depression within the past 12 months.
  • More than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with another prior SSRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
MGH Skin Picking Scale
Skin Picking Impact Scale
Skin Picking Treatment Scale
Clinical Global Impressions scale

Secondary Outcome Measures

Outcome Measure
Beck Depression Inventory
Beck Anxiety Inventory
Hamilton Depression Rating
Quality of Life Enjoyment and Satisfaction Scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Forest Laboratories

Investigators

  • Principal Investigator: Nancy J Keuthen, Ph.D., Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

June 20, 2005

First Submitted That Met QC Criteria

June 20, 2005

First Posted (Estimate)

June 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 20, 2008

Last Update Submitted That Met QC Criteria

May 19, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002-P-000888
  • 1200-211220
  • LXP-MD-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Impulse Control Disorders

Clinical Trials on Escitalopram

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe