Efficacy of Escitalopram in the Treatment of Internet Addiction - Full Text View

Sponsor:	Mount Sinai School of Medicine
Collaborator:	Forest Laboratories
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00565422

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 IV

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:

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

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:

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

Contacts and Locations

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):

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.

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
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 12, 2012