Escitalopram for the Treatment of Self-Injurious Skin Picking
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Impulse Control Disorders
Intervention: Escitalopram (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Nancy J Keuthen, Ph.D., Principal Investigator, Affiliation: Massachusetts General Hospital
Summary
The purpose of this study is to determine the effectiveness of escitalopram in treating
self-injurious skin picking.
Clinical Details
Official title: Escitalopram for the Treatment of Self-Injurious Skin Picking
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: MGH Skin Picking ScaleSkin Picking Impact Scale Skin Picking Treatment Scale Clinical Global Impressions scale
Secondary outcome: Hamilton Depression RatingBeck Depression Inventory Beck Anxiety Inventory Quality of Life Enjoyment and Satisfaction Scale
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): 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.
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Related publications: Gupta MA, Gupta AK, Haberman HF. Neurotic excoriations: a review and some new perspectives. Compr Psychiatry. 1986 Jul-Aug;27(4):381-6. 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. 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. 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. 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. 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.
Starting date: September 2002
Last updated: May 19, 2008
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