Major Depressive DisorderPhase 4NCT01198795

Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder

A Phase 4 study testing Escitalopram in people with Major Depressive Disorder, run by Forest Laboratories at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD). Read more about this study

Who is it for?: Ages 7 to 11 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Escitalopram
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 16 sitesUnited States
Study dates: Sep 2010to Apr 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 7 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female outpatients 7 to 11 years of age, inclusive
Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with a minimum duration of 6 weeks
Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about his or her condition, provides informed consent, and agrees to accompany the patient to all study visits. (Preferably the same parent, guardian, or LAR will accompany the patient to all study visits)
Patient's family is sufficiently organized and stable to guarantee adequate safety monitoring

Who cannot join

Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that was the primary focus of treatment
Patients with a diagnosis of conduct disorder will not be allowed to participate in this study
Current diagnosis of mental retardation, dementia, or amnestic or other cognitive disorders based on DSM-IV-TR criteria
History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or other drugs of the same class
Imminent risk of injuring self or others or causing significant damage to property, as judged by the PI
Suicide risk as determined by meeting any of the following criteria:
Any suicide attempt
Significant risk, as judged by the PI, based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS)

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Forest Investigative Site 017
Atlanta, Georgia, 30308
Forest Investigative Site 005
Bellevue, Washington, 98007
Forest Investigative Site 002
Cleveland, Ohio, 44106
Forest Investigative Site 014
Clinton, Utah, 84015
Forest Investigative Site 011
Creve Coeur, Missouri, 63141
Forest Investigative Site 010
Dallas, Texas, 75235
Forest Investigative Site 001
Dothan, Alabama, 36303
Forest Investigative Site 013
Jacksonville Beach, Florida, 32250
Forest Investigative Site 015
Kirkland, Washington, 98033
Forest Investigative Site 012
Oklahoma City, Oklahoma, 73116
Forest Investigative Site 007
Omaha, Nebraska, 68131
Forest Investigative Site 004
Overland Park, Kansas, 66211
Forest Investigative Site 003
Philadelphia, Pennsylvania, 19139
Forest Investigative Site 006
San Diego, California, 92108
Forest Investigative Site 018
Santa Ana, California, 92701
Forest Investigative Site 008
Washington D.C., District of Columbia, 20010-2970

Other trials in United States

About this study

Official title: An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder

This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD).

Conditions: Major Depressive Disorder
Being tested: Escitalopram
Keywords: depression, major depressive disorder, escitalopram, Lexapro, pediatric
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EscitalopramDrug
Also called Lexapro
Patients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.

Study groups in NCT01198795
Study group	Role	What they receive
1	Experimental	Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram Receives: Drug: Escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

Patients With Any Treatment Emergent Adverse Events (TEAEs)
The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,
Measured: From Baseline (Week 0) to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Apr 2013

First posted10 Sep 2010 (estimated)
Study startSep 2010
Primary completionJan 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
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: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01198795
Sponsor's protocol ID: SCT-MD-55
Status last verified: Jan 2014
First submitted: 9 Sep 2010
Last updated: 14 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
ClinicalTrials.gov ID: NCT01198795
Acronym / sponsor ID: SCT-MD-55
Conditions: Major Depressive Disorder
Keywords: depression, major depressive disorder, escitalopram, Lexapro, pediatric
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Jan 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 10 Sep 2010 (estimated)
Results: Posted 14 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: EscitalopramFlexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram

Who may qualify

Ages: 7 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Male or female outpatients 7 to 11 years of age, inclusive
Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with a minimum duration of 6 weeks
Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about his or her condition, provides informed consent, and agrees to accompany the patient to all study visits. (Preferably the same parent, guardian, or LAR will accompany the patient to all study visits)
Patient's family is sufficiently organized and stable to guarantee adequate safety monitoring

Key exclusion criteria (8 listed)

Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that was the primary focus of treatment
Patients with a diagnosis of conduct disorder will not be allowed to participate in this study
Current diagnosis of mental retardation, dementia, or amnestic or other cognitive disorders based on DSM-IV-TR criteria
History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or other drugs of the same class
Imminent risk of injuring self or others or causing significant damage to property, as judged by the PI

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: LexaproPatients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.	Drug	1

Primary outcome

Patients With Any Treatment Emergent Adverse Events (TEAEs)
Time frame: From Baseline (Week 0) to Week 26
The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,

Results and safety

Results posted to the registry on 14 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Escitalopram	162	80

Primary outcome: Patients With Any Treatment Emergent Adverse Events (TEAEs)

Time frame: From Baseline (Week 0) to Week 26. Number. Unit: participants

Measure	Escitalopram n = 118
Value	89

Adverse events

Time frame: Adverse event data was collected during a 28 month period from October 2010 to February 2013.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Escitalopram	2 of 118 (1.7%)	59 of 118 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
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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.

Suneeta Ahuja, PhD study chair

Forest Laboratories

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Escitalopram in people with Major Depressive Disorder, run by Forest Laboratories at 16 sites in United States.

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 4 inclusion and 8 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 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 14 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patients With Any Treatment Emergent Adverse Events (TEAEs) (time frame: From Baseline (Week 0) to Week 26). 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 NCT01198795.

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 14 Mar 2014.