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Efficacy of Escitalopram in the Treatment of Internet Addiction

Primary Purpose

Internet Addiction

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Escitalopram

About this trial

This is an interventional treatment trial for Internet Addiction focused on measuring Internet addiction, Problematic internet use, Escitalopram, Lexapro

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject has signed an informed consent form
Current diagnosis of Internet addiction
Age ³ 18
Subject must be able to take oral medication
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.
In the opinion of the investigator, the subject is capable of complying with all study procedures.

Exclusion Criteria:

Current suicidal or homicidal ideation
Subject has a primary diagnosis of schizophrenia or other psychotic disorders
Subject has a primary diagnosis of Bipolar I disorder
Current pedophilia
Current DSM-IV diagnosis of substance dependence or abuse, excluding nicotine
Women of child-bearing potential who are pregnant, nursing, or not using contraception
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)
Current use of antidepressants at a therapeutic level for the treatment of a disorder other than problematic internet use
Subject has any organic mental disorder
Clinically significant unstable medical disorder

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Escitalopram

Outcomes

Primary Outcome Measures

length of non-essential Internet use in hours/week as well as CGI-Improvement

Secondary Outcome Measures

ratings on depression, anxiety, impulsivity, self-esteem, obsessive-compulsive symptoms

Full Information

NCT ID

NCT00565422

First Posted

November 28, 2007

Last Updated

May 23, 2008

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00565422

Brief Title

Efficacy of Escitalopram in the Treatment of Internet Addiction

Official Title

Efficacy of Escitalopram in the Treatment of Internet Addiction

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Forest Laboratories

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Internet Addiction

Keywords

Internet addiction, Problematic internet use, Escitalopram, Lexapro

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

Escitalopram

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Other Intervention Name(s)

Lexapro

Intervention Description

10 mg/day

Primary Outcome Measure Information:

Title

length of non-essential Internet use in hours/week as well as CGI-Improvement

Time Frame

baseline and biweekly for 10 weeks

Secondary Outcome Measure Information:

Title

ratings on depression, anxiety, impulsivity, self-esteem, obsessive-compulsive symptoms

Time Frame

baseline and biweekly for 10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject has signed an informed consent form Current diagnosis of Internet addiction Age ³ 18 Subject must be able to take oral medication 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. In the opinion of the investigator, the subject is capable of complying with all study procedures. Exclusion Criteria: Current suicidal or homicidal ideation Subject has a primary diagnosis of schizophrenia or other psychotic disorders Subject has a primary diagnosis of Bipolar I disorder Current pedophilia Current DSM-IV diagnosis of substance dependence or abuse, excluding nicotine Women of child-bearing potential who are pregnant, nursing, or not using contraception 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) Current use of antidepressants at a therapeutic level for the treatment of a disorder other than problematic internet use Subject has any organic mental disorder Clinically significant unstable medical disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Hollander, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

18312057

Citation

Dell'Osso B, Hadley S, Allen A, Baker B, Chaplin WF, Hollander E. Escitalopram in the treatment of impulsive-compulsive internet usage disorder: an open-label trial followed by a double-blind discontinuation phase. J Clin Psychiatry. 2008 Mar;69(3):452-6. doi: 10.4088/jcp.v69n0316.

Results Reference

derived

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Efficacy of Escitalopram in the Treatment of Internet Addiction

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