Major Depressive DisorderPhase 3NCT00107120
The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
A Phase 3 study testing Escitalopram in people with Major Depressive Disorder, run by Forest Laboratories at 28 sites in United States.
Trial summary
Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 28 sitesUnited States
- Study dates
- Mar 2005to May 2007
- Phase
- Phase 3
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
- Patient's current depressive episode must be at least 12 weeks in duration
- Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.
Who cannot join
- Patients who currently meet DSM-IV criteria for:
- attention deficit-hyperactivity disorder
- obsessive-compulsive disorder
- posttraumatic stress disorder
- bipolar disorder
- pervasive developmental disorder
Show all 10Show fewer
- mental retardation
- conduct disorder
- oppositional defiant disorder
- Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
Northwest Clinical Research Center
Bellevue, Washington, 98004
North Carolina Neuropsychiatry, PA
Chapel Hill, North Carolina, 27514
University of Cincinnati College of Medicine, Children's Hospital Medical Center
Cincinnati, Ohio, 45229
CNS Research Institute
Clementon, New Jersey, 08021
University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center, Center for Pediatric Psychiatry
Dallas, Texas, 75235
University of Florida - Child Study Program
Gainesville, Florida, 32610
University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences
Galveston, Texas, 77555
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
Capstone Clinical Research
Libertyville, Illinois, 60048
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
IPS Research Company
Oklahoma City, Oklahoma, 73103
Creighton University Medical School, Department of Psychiatry
Omaha, Nebraska, 68131
Psychiatric Associates
Overland, Kansas, 66211
University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section
Philadelphia, Pennsylvania, 19104
Drexel University College of Medicine, Friends Hospital
Philadelphia, Pennsylvania, 19124
Capitol Clinical Research Associates
Rockville, Maryland, 20852
University of California at Davis, MIND Institute, Health Services
Sacramento, California, 95817
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63301
UCSD Outpatient Psychiatry Services
San Diego, California, 92103
PCSD - Feighner Research
San Diego, California, 92111
Pulmonary and Allergy Associates, P. A.
Summit, New Jersey, 07901
Clinco
Terre Haute, Indiana, 47802
Brighton Research Group, LLC
Virginia Beach, Virginia, 23452
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
Kolin Research Group
Winter Park, Florida, 32789
About this study
Official title: A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram, Placebo
- Keywords
- Major Depressive Disorder, Depression, Adolescents, Escitalopram, Pediatrics
- 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 (TM)
Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
PlaceboDrug
Placebo once daily for up to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks Receives: Drug: Escitalopram |
| 2 | Placebo comparator | Placebo once daily for up to 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.
Measured: Baseline to end of week 8
Secondary outcomes (1)
Clinical Global Impressions - Improvement
Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse).
Measured: CGI-I score at the end of Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2005 (estimated)
- Study startMar 2005
- Primary completionMay 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Ventura, PhD, Study director, Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107120
- Sponsor's protocol ID
- SCT-MD-32
- Status last verified
- Apr 2012
- First submitted
- 5 Apr 2005
- Last updated
- 6 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Emslie GJ, Ventura D, Korotzer A, Tourkodimitris S. Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. J Am Acad Child Adolesc Psychiatry. 2009 Jul;48(7):721-729. doi: 10.1097/CHI.0b013e3181a2b304.
PubMed 19465881
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00107120
- Acronym / sponsor ID
- SCT-MD-32
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Depression, Adolescents, Escitalopram, Pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- May 2007 (actual)
- First posted
- 6 Apr 2005 (estimated)
- Results
- Posted 4 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: EscitalopramEscitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks |
| 2 | Placebo comparator | Drug: PlaceboPlacebo once daily for up to 8 weeks |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
- Patient's current depressive episode must be at least 12 weeks in duration
- Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.
Key exclusion criteria (10 listed)
- Patients who currently meet DSM-IV criteria for:
- Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.
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: Lexapro (TM)Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks | Drug | Escitalopram |
| PlaceboPlacebo once daily for up to 8 weeks | Drug | 2 |
Primary outcome
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
Time frame: Baseline to end of week 8
Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.
1 secondary outcome
Clinical Global Impressions - Improvement
Time frame: CGI-I score at the end of Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19465881Emslie GJ, Ventura D, Korotzer A, Tourkodimitris S. Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. J Am Acad Child Adolesc Psychiatry. 2009 Jul;48(7):721-729. doi: 10.1097/CHI.0b013e3181a2b304.
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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.
Daniel Ventura, PhD study director
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Escitalopram in people with Major Depressive Disorder, run by Forest Laboratories at 28 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 3 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 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Nov 2009). 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?
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (time frame: Baseline to end of week 8). 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 NCT00107120, 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 6 Apr 2012.