Escitalopram for the Treatment of Self-Injurious Skin Picking

Impulse Control Disorders Clinical Trial

Official title:

Escitalopram for the Treatment of Self-Injurious Skin Picking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115011
• Other study ID #: 2002-P-000888
• Secondary ID: LXP-MD-361200-21
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2005
• Last updated: May 19, 2008
• Start date: September 2002
• Est. completion date: November 2005

Study information

• Verified date: May 2008
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impulse Control Disorders

Intervention

Drug:
• Escitalopram

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Forest Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (6)

Arnold LM, Mutasim DF, Dwight MM, Lamerson CL, Morris EM, McElroy SL. An open clinical trial of fluvoxamine treatment of psychogenic excoriation. J Clin Psychopharmacol. 1999 Feb;19(1):15-8. — View Citation

Gupta MA, Gupta AK, Haberman HF. Neurotic excoriations: a review and some new perspectives. Compr Psychiatry. 1986 Jul-Aug;27(4):381-6. — View Citation

Kalivas J, Kalivas L, Gilman D, Hayden CT. Sertraline in the treatment of neurotic excoriations and related disorders. Arch Dermatol. 1996 May;132(5):589-90. — View Citation

Keuthen NJ, Deckersbach T, Wilhelm S, Hale E, Fraim C, Baer L, O'Sullivan RL, Jenike MA. Repetitive skin-picking in a student population and comparison with a sample of self-injurious skin-pickers. Psychosomatics. 2000 May-Jun;41(3):210-5. — View Citation

O'Sullivan RL, Phillips KA, Keuthen NJ, Wilhelm S. Near-fatal skin picking from delusional body dysmorphic disorder responsive to fluvoxamine. Psychosomatics. 1999 Jan-Feb;40(1):79-81. — View Citation

Simeon D, Stein DJ, Gross S, Islam N, Schmeidler J, Hollander E. A double-blind trial of fluoxetine in pathologic skin picking. J Clin Psychiatry. 1997 Aug;58(8):341-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MGH Skin Picking Scale
Primary	Skin Picking Impact Scale
Primary	Skin Picking Treatment Scale
Primary	Clinical Global Impressions scale
Secondary	Hamilton Depression Rating
Secondary	Beck Depression Inventory
Secondary	Beck Anxiety Inventory
Secondary	Quality of Life Enjoyment and Satisfaction Scale