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Completed

NCT Number: NCT00115011

Escitalopram for the Treatment of Self-Injurious Skin Picking

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

Primary outcomes

  1. MGH Skin Picking Scale

  2. Skin Picking Impact Scale

  3. Skin Picking Treatment Scale

  4. Clinical Global Impressions scale

Secondary outcomes

  1. Hamilton Depression Rating

  2. Beck Depression Inventory

  3. Beck Anxiety Inventory

  4. Quality of Life Enjoyment and Satisfaction Scale

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Forest Laboratories

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Jun 21, 2005
Registry last updated
May 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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