Major Depressive DisorderPhase 3NCT00108979
Study of 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 9 sites in United States.
Trial summary
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 evaluate the efficacy, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Escitalopram
- How many people
- 240 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2005to Jul 2006
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
- The patient's current depressive episode must be at least 12 weeks in duration.
Who cannot join
- Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
- Patients who currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
- Patients who are considered a suicide risk.
- Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Northwest Clinical Research Center
Bellevue, Washington, 98004
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
Summit Research Network
Okemos, Michigan, 48864
University of Nebraska Medical Center
Omaha, Nebraska, 68198
CNS Research Institute
Philadelphia, Pennsylvania, 19149
Southwest Health, Ltd.
Phoenix, Arizona, 85016
Summit Research Network
Portland, Oregon, 97210
Radiant Research
Salt Lake City, Utah, 84107
Summit Research Network
Seattle, Washington, 98104
About this study
Official title: Double-Blind Study of Escitalopram in Adult Patients With Major Depressive Disorder
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 evaluate the efficacy, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major depressive disorder.
- Conditions
- Major Depressive Disorder
- Being tested
- Escitalopram
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS)
Secondary outcomes (1)
Hamilton Depression Rating Scale (HAMD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2005 (estimated)
- Study startMar 2005
- Primary completionJul 2006
- Study completionJul 2006
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 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
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108979
- Sponsor's protocol ID
- SCT-MD-23
- Status last verified
- Mar 2012
- First submitted
- 21 Apr 2005
- Last updated
- 5 Mar 2012
- Results posted
- No
Publications
Signorovitch J, Ramakrishnan K, Ben-Hamadi R, Yu AP, Wu EQ, Dworak H, Erder MH. Remission of major depressive disorder without adverse events: a comparison of escitalopram versus serotonin norepinephrine reuptake inhibitors. Curr Med Res Opin. 2011 Jun;27(6):1089-96. doi: 10.1185/03007995.2011.567255. Epub 2011 Mar 28.
PubMed 21438794
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Study of Escitalopram in Adult Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00108979
- Acronym / sponsor ID
- SCT-MD-23
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Major Depressive Disorder, Escitalopram
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 22 Apr 2005 (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.
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 evaluate the efficacy, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major depressive disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 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 (DSM-IV) diagnostic criteria for Major Depressive Disorder.
- The patient's current depressive episode must be at least 12 weeks in duration.
Key exclusion criteria (4 listed)
- Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
- Patients who currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
- Patients who are considered a suicide risk.
- Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of 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 |
|---|---|---|
| Escitalopram | Drug | – |
Primary outcome
Montgomery Asberg Depression Rating Scale (MADRS)
1 secondary outcome
Hamilton Depression Rating Scale (HAMD)
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 5 Mar 2012.
- Derived from this study: PubMed 21438794Signorovitch J, Ramakrishnan K, Ben-Hamadi R, Yu AP, Wu EQ, Dworak H, Erder MH. Remission of major depressive disorder without adverse events: a comparison of escitalopram versus serotonin norepinephrine reuptake inhibitors. Curr Med Res Opin. 2011 Jun;27(6):1089-96. doi: 10.1185/03007995.2011.567255. Epub 2011 Mar 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 9 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 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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?
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?
Montgomery Asberg Depression Rating Scale (MADRS). 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 NCT00108979, 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 5 Mar 2012.