Escitalopram for the Treatment of Self-Injurious Skin Picking - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	Forest Laboratories
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00115011

Purpose

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

Condition	Intervention	Phase
Impulse Control Disorders	Drug: Escitalopram	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Escitalopram for the Treatment of Self-Injurious Skin Picking

Resource links provided by NLM:

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

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

Enrollment:	30
Study Start Date:	September 2002
Study Completion Date:	November 2005

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115011

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Forest Laboratories

Investigators

Principal Investigator:

Nancy J Keuthen, Ph.D.

Massachusetts General Hospital

More Information

Publications:

Gupta MA, Gupta AK, Haberman HF. Neurotic excoriations: a review and some new perspectives. Compr Psychiatry. 1986 Jul-Aug;27(4):381-6. No abstract available.

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. No abstract available.

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. No abstract available.

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.

Responsible Party:	Massachusetts General Hospital ( Darin Dougherty, MD )
Study ID Numbers:	2002-P-000888, LXP-MD-36, 1200-211220
Study First Received:	June 20, 2005
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00115011 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

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

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Serotonin Uptake Inhibitors
Citalopram

Pharmacologic Actions
Muscarinic Antagonists
Impulse Control Disorders
Serotonin Agents
Mental Disorders
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Dexetimide
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010