Efficacy of Escitalopram in the Treatment of Internet Addiction

Internet Addiction Clinical Trial

Official title:

Efficacy of Escitalopram in the Treatment of Internet Addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565422
• Other study ID #: LXP-MD-09
• Secondary ID: 01-1174
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2007
• Last updated: May 23, 2008
• Start date: December 2002
• Est. completion date: October 2004

Study information

• Verified date: May 2008
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and effective in treating problematic internet use.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavior, Addictive
• Internet Addiction

Intervention

Drug:
• Escitalopram
10 mg/day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Forest Laboratories

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of non-essential Internet use in hours/week as well as CGI-Improvement		baseline and biweekly for 10 weeks	No
Secondary	ratings on depression, anxiety, impulsivity, self-esteem, obsessive-compulsive symptoms		baseline and biweekly for 10 weeks	No