Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
1 other identifier
interventional
540
1 country
18
Brief 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 and safety of a fixed-dose escitalopram combination relative to its component monotherapies and to placebo in patients with major depressive disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 major-depressive-disorder
Started Mar 2005
Shorter than P25 for phase_3 major-depressive-disorder
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 22, 2005
CompletedFirst Posted
Study publicly available on registry
April 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedMarch 5, 2012
March 1, 2012
1.2 years
April 22, 2005
March 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Montgomery Asberg Depression Rating Scale (MADRS)
Secondary Outcomes (1)
Hamilton Depression Rating Scale (HAMD)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Southwest Health, Ltd
Phoenix, Arizona, 85016, United States
Alpine Clinical Research
Boulder, Colorado, 80304, United States
Radiant Research, Inc.
Denver, Colorado, 80212, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Cunningham Clinical Research, LLC
Edwardsville, Illinois, 62025, United States
Midwest Center for Neurobiological Medicine
Oakbrook Terrace, Illinois, 60181, United States
Capital Clinical Research Associates
Rockville, Maryland, 20852, United States
Summit Research Network (Michigan), Inc.
Okemos, Michigan, 48864, United States
CNS Research Institute
Clementon, New Jersey, 08021, United States
Center for Emotional Fitness
Moorestown, New Jersey, 08057, United States
Eastside Comprehensive Medical Center
New York, New York, 10021, United States
Piedmont Medical Research Associates, Inc.
Winston-Salem, North Carolina, 27103, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401, United States
Croft Group Research Center
San Antonio, Texas, 78229, United States
Dominion Clinical Research
Midlothian, Virginia, 23112-3989, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Summit Research Network (Seattle), LLC
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2005
First Posted
April 25, 2005
Study Start
March 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
March 5, 2012
Record last verified: 2012-03