Escitalopram for the Treatment of Self-Injurious Skin Picking

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00115011
First received: June 20, 2005
Last updated: May 19, 2008
Last verified: May 2008
  Purpose

The purpose of this study is to determine the effectiveness of escitalopram in treating self-injurious skin picking.


Condition Intervention Phase
Impulse Control Disorders
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Escitalopram for the Treatment of Self-Injurious Skin Picking

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • MGH Skin Picking Scale
  • Skin Picking Impact Scale
  • Skin Picking Treatment Scale
  • Clinical Global Impressions scale

Secondary Outcome Measures:
  • Hamilton Depression Rating
  • Beck Depression Inventory
  • Beck Anxiety Inventory
  • Quality of Life Enjoyment and Satisfaction Scale

Enrollment: 30
Study Start Date: September 2002
Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115011

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Forest Laboratories
Investigators
Principal Investigator: Nancy J Keuthen, Ph.D. Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Darin Dougherty, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00115011     History of Changes
Other Study ID Numbers: 2002-P-000888, LXP-MD-36, 1200-211220
Study First Received: June 20, 2005
Last Updated: May 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Skin Picking
Escitalopram
Lexapro
Body Focused Repetitive Behaviors
Obsessive Compulsive Spectrum Disorders

Additional relevant MeSH terms:
Impulse Control Disorders
Mental Disorders
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014