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Escitalopram for the Treatment of Self-Injurious Skin Picking

NCT ID: NCT00115011

Last Updated: 2008-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2005-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Impulse Control Disorders

Keywords

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Skin Picking Escitalopram Lexapro Body Focused Repetitive Behaviors Obsessive Compulsive Spectrum Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Escitalopram

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hospital

Principal Investigators

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Nancy J Keuthen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 3731771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10849452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9989126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9515971 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8624163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9934938 (View on PubMed)

Other Identifiers

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LXP-MD-36

Identifier Type: -

Identifier Source: secondary_id

1200-211220

Identifier Type: -

Identifier Source: secondary_id

2002-P-000888

Identifier Type: -

Identifier Source: org_study_id