NCT00565422

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2002

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

December 1, 2002

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
Last Updated

May 28, 2008

Status Verified

May 1, 2008

First QC Date

November 28, 2007

Last Update Submit

May 23, 2008

Conditions

Keywords

Internet addictionProblematic internet useEscitalopramLexapro

Outcome Measures

Primary Outcomes (1)

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

    baseline and biweekly for 10 weeks

Secondary Outcomes (1)

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

    baseline and biweekly for 10 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Escitalopram

Drug: Escitalopram

Interventions

10 mg/day

Also known as: Lexapro
Single Arm

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Internet Addiction Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Eric Hollander, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 30, 2007

Study Start

December 1, 2002

Study Completion

October 1, 2004

Last Updated

May 28, 2008

Record last verified: 2008-05