NCT00115011

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

May 20, 2008

Status Verified

May 1, 2008

First QC Date

June 20, 2005

Last Update Submit

May 19, 2008

Conditions

Keywords

Skin PickingEscitalopramLexaproBody Focused Repetitive BehaviorsObsessive Compulsive Spectrum Disorders

Outcome Measures

Primary Outcomes (4)

  • MGH Skin Picking Scale

  • Skin Picking Impact Scale

  • Skin Picking Treatment Scale

  • Clinical Global Impressions scale

Secondary Outcomes (4)

  • Hamilton Depression Rating

  • Beck Depression Inventory

  • Beck Anxiety Inventory

  • Quality of Life Enjoyment and Satisfaction Scale

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

  • 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.

    PMID: 3731771BACKGROUND
  • 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.

    PMID: 10849452BACKGROUND
  • 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.

    PMID: 9989126BACKGROUND
  • 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.

    PMID: 9515971BACKGROUND
  • 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.

    PMID: 8624163BACKGROUND
  • 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.

    PMID: 9934938BACKGROUND

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct DisordersExcoriation Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Mental DisordersSelf-Injurious BehaviorBehavioral SymptomsBehaviorObsessive-Compulsive DisorderAnxiety Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Nancy J Keuthen, Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2005

First Posted

June 21, 2005

Study Start

September 1, 2002

Study Completion

November 1, 2005

Last Updated

May 20, 2008

Record last verified: 2008-05

Locations