The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and effective in treating problematic internet use...
Date First Received: November 28, 2007
Last Updated: May 23, 2008
Verified by: Mount Sinai School of Medicine, May 2008
Clinical Trial Phase: Phase 4 | Start Date: December 2002
Overall Status: Completed
Estimated Enrollment: 31
Brief Summary
Official Title: “Efficacy of Escitalopram in the Treatment of Internet Addiction”
Condition Keyword(s):
Intervention(s):
The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and effective in treating problematic internet use.
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
Many individuals experience marked distress and functional impairments as a result of their perceived inability to control their 'non-essential' (non-job/school related) use of the Internet. Frequently these people develop a preoccupation with the Internet, a need for escape to the Internet, and increasing irritability when trying to cut back use of the Internet. There have been no studies to date looking at the effectiveness of medications in the treatment of this disorder. In our clinical experience, we find these patients with Internet addiction usually respond to serotonin reuptake inhibitors within 12 weeks. This study will examine the efficacy of escitalopram in Internet addiction among adults.
Intervention(s) in this Clinical Trial
- Drug: Escitalopram
- 10 mg/day
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Single Arm
- Escitalopram
Outcome Measures for this Clinical Trial
Primary Measures
- length of non-essential Internet use in hours/week as well as CGI-Improvement
- Time Frame: baseline and biweekly for 10 weeks
Safety Issue?: No
- Time Frame: baseline and biweekly for 10 weeks
Secondary Measures
- ratings on depression, anxiety, impulsivity, self-esteem, obsessive-compulsive symptoms
- Time Frame: baseline and biweekly for 10 weeks
Safety Issue?: No
- Time Frame: baseline and biweekly for 10 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 1. Subject has signed an informed consent form
- 2. Current diagnosis of Internet addiction
- 3. Age ³ 18
- 4. Subject must be able to take oral medication
- 5. Subject may be in psychotherapy initiated at least three months prior to Screening.
- Subject must not discontinue or otherwise alter this therapy during the study.
- 6. In the opinion of the investigator, the subject is capable of complying with all study procedures.
Exclusion Criteria:
- 1. Current suicidal or homicidal ideation
- 2. Subject has a primary diagnosis of schizophrenia or other psychotic disorders
- 3. Subject has a primary diagnosis of Bipolar I disorder
- 4. Current pedophilia
- 5. Current DSM-IV diagnosis of substance dependence or abuse, excluding nicotine
- 6. Women of child-bearing potential who are pregnant, nursing, or not using contraception
- 7. Use of antidepressants at a therapeutic level for the treatment of problematic internet use within 2 weeks prior to study entry (or 4 weeks for use of MAOIs, or 6 weeks for use of fluoxetine)
- 8. Current use of antidepressants at a therapeutic level for the treatment of a disorder other than problematic internet use
- 9. Subject has any organic mental disorder
- 10. Clinically significant unstable medical disorder
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Mount Sinai School of Medicine
Overall Clinical Trial Officials and Contacts
Eric Hollander, MD Principal Investigator Mount Sinai School of Medicine
Additional Information
Information obtained from ClinicalTrials.gov on January 08, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00565422
Study ID Number: LXP-MD-09
ClinicalTrials.gov Identifier: NCT00565422
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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