Major Depressive DisorderPhase 3NCT00668525
Escitalopram in Adult Patients With Major Depressive Disorder
A Phase 3 study testing Escitalopram in people with Major Depressive Disorder, run by Forest Laboratories at 45 sites in United States.
Trial summary
This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram. Read more about this study
- Who is it for?
- Ages 18 to 65 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?
- Yes, some participants may receive a placebo
- How many people
- 877 participants
- Where
- 45 sitesUnited States
- Study dates
- Apr 2008to Feb 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.
- The patient's current depressive episode must be at least 8 weeks in duration.
Who cannot join
- Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
- Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
- Patients who are considered a suicide risk
- Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Forest Investigative Site
Arcadia, California, 91007
Forest Investigative Site
Atlanta, Georgia, 30328
Forest Investigative Site
Austin, Texas, 78756
Forest Investigative Site
Baltimore, Maryland, 21208
Forest Investigative Site
Bellevue, Washington, 98004
Forest Investigative Site
Bradenton, Florida, 34208
Forest Investigative Site
Brooklyn, New York, 11235
Forest Investigative Site
Canton, Ohio, 44708
Forest Investigative Site
Charleston, South Carolina, 29405
Forest Investigative Site
Cherry Hill, New Jersey, 08002
Forest Investigative Site
Clementon, New Jersey, 08021
Forest Investigative Site
Dayton, Ohio, 45408
Forest Investigative Site
Denver, Colorado, 80212
Forest Investigative Site
Encino, California, 91316
Forest Investigative Site
Garden Grove, California, 92845
Forest Investigative Site
Glen Burnie, Maryland, 21061
Forest Investigative Site
Houston, Texas, 77008
Forest Investigative Site
Irvine, California, 92618
Forest Investigative Site
Jacksonville, Florida, 32216
Forest Investigative Site
Los Alamitos, California, 90720
Forest Investigative Site
Media, Pennsylvania, 19063
Forest Investigative Site
Memphis, Tennessee, 38117
Forest Investigative Site
Memphis, Tennessee, 38119
Forest Investigative Site
New York, New York, 10021
Forest Investigative Site
New York, New York, 10024
Forest Investigative Site
Newton, Kansas, 67114
Forest Investigative Site
Okemos, Michigan, 48864
Forest Investigative Site
Omaha, Nebraska, 68131
Forest Investigative Site
Omaha, Nebraska, 68198
Forest Investigative Site
Orlando, Florida, 32806
Forest Investigative Site
Overland, Kansas, 66221
Forest Investigative Site
Philadelphia, Pennsylvania, 19107
Forest Investigative Site
Phoenix, Arizona, 85016
Forest Investigative Site
Portland, Oregon, 97210
Forest Investigative Site
Richmond, Virginia, 23230
Forest Investigative Site
Rockville, Maryland, 20852
Forest Investigative Site
Salt Lake City, Utah, 84107
Forest Investigative Site
San Antonio, Texas, 78229
Forest Investigative Site
Seattle, Washington, 98104
Forest Investigative Site
St Louis, Missouri, 63044
Forest Investigative Site
Staten Island, New York, 10312
Forest Investigative Site
The Bronx, New York, 10467
Forest Investigative Site
Washington D.C., District of Columbia, 20016
Forest Investigative Site
West Palm Beach, Florida, 33407
Forest Investigative Site
Woodstock, Vermont, 05091
About this study
Official title: A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder
This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram, Placebo
- Keywords
- Depression, Major Depressive Disorder, Escitalopram
- 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
Escitalopram low dose, oral administration, once daily dosing for 8 weeks.
PlaceboDrug
Placebo, oral administration, once daily dosing for 8 weeks
EscitalopramDrug
Escitalopram high dose, oral administration, once daily dosing for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Escitalopram low dose Receives: Drug: Escitalopram |
| 3 | Experimental | Escitalopram high dose Receives: Drug: Escitalopram |
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.
The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).
Measured: Change from baseline in MADRS total score at week 8
Secondary outcomes (1)
Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8
The HAMD is a clinician-rated 24-item scale was used to rate the patient's depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state).
Measured: Change from baseline in HAM-D at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 877 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carl Gommoll, MS, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668525
- Sponsor's protocol ID
- SCT-MD-49
- Status last verified
- May 2010
- First submitted
- 28 Apr 2008
- Last updated
- 11 May 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00668525
- Acronym / sponsor ID
- SCT-MD-49
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Major Depressive Disorder, Escitalopram
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 877 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Feb 2009 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Posted 6 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: EscitalopramEscitalopram low dose |
| 3 | Experimental | Drug: EscitalopramEscitalopram high dose |
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.
- The patient's current depressive episode must be at least 8 weeks in duration.
Key exclusion criteria (4 listed)
- Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
- Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
- Patients who are considered a suicide risk
- Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.
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 |
|---|---|---|
| EscitalopramEscitalopram low dose, oral administration, once daily dosing for 8 weeks. | Drug | 2 |
| PlaceboPlacebo, oral administration, once daily dosing for 8 weeks | Drug | 1 |
| EscitalopramEscitalopram high dose, oral administration, once daily dosing for 8 weeks | Drug | 3 |
Primary outcome
Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.
Time frame: Change from baseline in MADRS total score at week 8
The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).
1 secondary outcome
Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8
Time frame: Change from baseline in HAM-D at week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carl Gommoll, MS study director
Forest Laboratories
45 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 45 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 2 inclusion and 4 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 11 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 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 6 May 2010). 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 From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. (time frame: Change from baseline in MADRS total score at week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2010.