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Trial record 6 of 9 for:    "Impulse Control Disorder" | "Peripheral Nervous System Agents"

Escitalopram for the Treatment of Self-Injurious Skin Picking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115011
Recruitment Status : Completed
First Posted : June 21, 2005
Last Update Posted : May 20, 2008
Forest Laboratories
Information provided by:
Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Impulse Control Disorders Drug: Escitalopram Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Escitalopram for the Treatment of Self-Injurious Skin Picking
Study Start Date : September 2002
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. MGH Skin Picking Scale
  2. Skin Picking Impact Scale
  3. Skin Picking Treatment Scale
  4. Clinical Global Impressions scale

Secondary Outcome Measures :
  1. Hamilton Depression Rating
  2. Beck Depression Inventory
  3. Beck Anxiety Inventory
  4. Quality of Life Enjoyment and Satisfaction Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00115011

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

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Responsible Party: Darin Dougherty, MD, Massachusetts General Hospital Identifier: NCT00115011     History of Changes
Other Study ID Numbers: 2002-P-000888
First Posted: June 21, 2005    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008
Keywords provided by Massachusetts General Hospital:
Skin Picking
Body Focused Repetitive Behaviors
Obsessive Compulsive Spectrum Disorders
Additional relevant MeSH terms:
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Peripheral Nervous System Agents
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents