Efficacy of Escitalopram in the Treatment of Internet Addiction

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00565422
First received: November 28, 2007
Last updated: May 23, 2008
Last verified: May 2008
  Purpose

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


Condition Intervention Phase
Internet Addiction
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Escitalopram in the Treatment of Internet Addiction

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • length of non-essential Internet use in hours/week as well as CGI-Improvement [ Time Frame: baseline and biweekly for 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ratings on depression, anxiety, impulsivity, self-esteem, obsessive-compulsive symptoms [ Time Frame: baseline and biweekly for 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: December 2002
Study Completion Date: October 2004
Arms Assigned Interventions
Experimental: Single Arm
Escitalopram
Drug: Escitalopram
10 mg/day
Other Name: Lexapro

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565422

Sponsors and Collaborators
Mount Sinai School of Medicine
Forest Laboratories
Investigators
Principal Investigator: Eric Hollander, MD Mount Sinai School of Medicine
  More Information

No publications provided by Mount Sinai School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Eric Hollander, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00565422     History of Changes
Other Study ID Numbers: LXP-MD-09, 01-1174
Study First Received: November 28, 2007
Last Updated: May 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Internet addiction
Problematic internet use
Escitalopram
Lexapro

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014