- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00565422
Efficacy of Escitalopram in the Treatment of Internet Addiction
May 23, 2008 updated by: Icahn School of Medicine at Mount Sinai
The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and effective in treating problematic internet use.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single Arm
Escitalopram
|
10 mg/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
length of non-essential Internet use in hours/week as well as CGI-Improvement
Time Frame: baseline and biweekly for 10 weeks
|
baseline and biweekly for 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ratings on depression, anxiety, impulsivity, self-esteem, obsessive-compulsive symptoms
Time Frame: baseline and biweekly for 10 weeks
|
baseline and biweekly for 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Study Completion (ACTUAL)
October 1, 2004
Study Registration Dates
First Submitted
November 28, 2007
First Submitted That Met QC Criteria
November 29, 2007
First Posted (ESTIMATE)
November 30, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
May 28, 2008
Last Update Submitted That Met QC Criteria
May 23, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Compulsive Behavior
- Impulsive Behavior
- Behavior, Addictive
- Internet Addiction Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- LXP-MD-09
- 01-1174
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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