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Escitalopram for the Treatment of Self-Injurious Skin Picking

Primary Purpose

Impulse Control Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impulse Control Disorders focused on measuring Skin Picking, Escitalopram, Lexapro, Body Focused Repetitive Behaviors, Obsessive Compulsive Spectrum Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

MGH Skin Picking Scale
Skin Picking Impact Scale
Skin Picking Treatment Scale
Clinical Global Impressions scale

Secondary Outcome Measures

Hamilton Depression Rating
Beck Depression Inventory
Beck Anxiety Inventory
Quality of Life Enjoyment and Satisfaction Scale

Full Information

First Posted
June 20, 2005
Last Updated
May 19, 2008
Sponsor
Massachusetts General Hospital
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00115011
Brief Title
Escitalopram for the Treatment of Self-Injurious Skin Picking
Official Title
Escitalopram for the Treatment of Self-Injurious Skin Picking
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulse Control Disorders
Keywords
Skin Picking, Escitalopram, Lexapro, Body Focused Repetitive Behaviors, Obsessive Compulsive Spectrum Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Escitalopram
Primary Outcome Measure Information:
Title
MGH Skin Picking Scale
Title
Skin Picking Impact Scale
Title
Skin Picking Treatment Scale
Title
Clinical Global Impressions scale
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating
Title
Beck Depression Inventory
Title
Beck Anxiety Inventory
Title
Quality of Life Enjoyment and Satisfaction Scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy J Keuthen, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3731771
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.
Results Reference
background
PubMed Identifier
10849452
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.
Results Reference
background
PubMed Identifier
9989126
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.
Results Reference
background
PubMed Identifier
9515971
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.
Results Reference
background
PubMed Identifier
8624163
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.
Results Reference
background
PubMed Identifier
9934938
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.
Results Reference
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Escitalopram for the Treatment of Self-Injurious Skin Picking

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