Escitalopram for the Treatment of Self-Injurious Skin Picking
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Escitalopram for the Treatment of Self-Injurious Skin Picking |
- MGH Skin Picking Scale
- Skin Picking Impact Scale
- Skin Picking Treatment Scale
- Clinical Global Impressions scale
- 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 |
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 |
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| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Nancy J Keuthen, Ph.D. | Massachusetts General Hospital |
More Information
Publications:
| Responsible Party: | Darin Dougherty, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00115011 History of Changes |
| Other Study ID Numbers: | 2002-P-000888, LXP-MD-36, 1200-211220 |
| Study First Received: | June 20, 2005 |
| Last Updated: | May 19, 2008 |
| 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:
|
Impulse Control Disorders Mental Disorders Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 23, 2013