Internet AddictionPhase 4NCT00565422
Efficacy of Escitalopram in the Treatment of Internet Addiction
A Phase 4 study testing Escitalopram in people with Internet Addiction, run by Icahn School of Medicine at Mount Sinai.
Trial summary
The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and effective in treating problematic internet use. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Internet Addiction
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Oct 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and effective in treating problematic internet use.
Read the 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.
- Conditions
- Internet Addiction
- Being tested
- Escitalopram
- Keywords
- Internet addiction, Problematic internet use, Escitalopram, Lexapro
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
10 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Escitalopram Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of non-essential Internet use in hours/week as well as CGI-Improvement
Measured: baseline and biweekly for 10 weeks
Secondary outcomes (1)
ratings on depression, anxiety, impulsivity, self-esteem, obsessive-compulsive symptoms
Measured: baseline and biweekly for 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startDec 2002
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Internet AddictionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Eric Hollander, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565422
- Sponsor's protocol ID
- LXP-MD-09
- Other IDs
- 01-1174
- Status last verified
- May 2008
- First submitted
- 28 Nov 2007
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18312057
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Escitalopram in the Treatment of Internet Addiction
- ClinicalTrials.gov ID
- NCT00565422
- Acronym / sponsor ID
- LXP-MD-09
- Conditions
- Internet Addiction
- Keywords
- Internet addiction, Problematic internet use, Escitalopram, Lexapro
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Dec 2002
- Study completion
- Oct 2004 (actual)
- First posted
- 30 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: EscitalopramEscitalopram |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: Lexapro10 mg/day | Drug | Single Arm |
Primary outcome
length of non-essential Internet use in hours/week as well as CGI-Improvement
Time frame: baseline and biweekly for 10 weeks
1 secondary outcome
ratings on depression, anxiety, impulsivity, self-esteem, obsessive-compulsive symptoms
Time frame: baseline and biweekly for 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
- Derived from this study: PubMed 18312057Dell'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hollander, MD principal investigator
Icahn School of Medicine at Mount Sinai
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram in people with Internet Addiction, run by Icahn School of Medicine at Mount Sinai.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of non-essential Internet use in hours/week as well as CGI-Improvement (time frame: baseline and biweekly for 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00565422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2008.