Clinical trial NCT00115011: Escitalopram for the Treatment of Self-Injurious Skin Picking
Official title: Escitalopram for the Treatment of Self-Injurious Skin Picking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impulse Control Disorders
Keywords: Skin Picking
Escitalopram
Lexapro
Body Focused Repetitive Behaviors
Obsessive Compulsive Spectrum Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2005-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: MGH Skin Picking Scale
measure: Skin Picking Impact Scale
measure: Skin Picking Treatment Scale
measure: Clinical Global Impressions scale
Secondary outcomes:
measure: Hamilton Depression Rating
measure: Beck Depression Inventory
measure: Beck Anxiety Inventory
measure: Quality of Life Enjoyment and Satisfaction Scale
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy J Keuthen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gupta MA, Gupta AK, Haberman HF. Neurotic excoriations: a review and some new perspectives. Compr Psychiatry. 1986 Jul-Aug;27(4):381-6. doi: 10.1016/0010-440x(86)90014-3. No abstract available.
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. doi: 10.1176/appi.psy.41.3.210.
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. doi: 10.1016/S0033-3182(99)71276-4. No abstract available.
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. doi: 10.4088/jcp.v58n0802.
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. doi: 10.1001/archderm.1996.03890290131022. No abstract available.
citation: 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. doi: 10.1097/00004714-199902000-00005.