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 IV

Further Study Details: 

Primary Outcomes: MGH Skin Picking Scale; Skin Picking Impact Scale; Skin Picking Treatment Scale; Clinical Global Impressions scale
Secondary Outcomes: Hamilton Depression Rating; Beck Depression Inventory; Beck Anxiety Inventory; Quality of Life Enjoyment and Satisfaction Scale
Expected Total Enrollment:  30

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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.

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

Study chairs or principal investigators

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

Study ID Numbers:  2002-P-000888; LXP-MD-36; 1200-211220
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 20, 2005
ClinicalTrials.gov Identifier:  NCT00115011
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05