Clinical trial NCT00109044: Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
Official title: Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Major Depressive Disorder
Escitalopram
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2005-04-25
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS)
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HAMD)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Health, Ltd
state: Arizona
city: Boulder
country: United States
facility: Alpine Clinical Research
state: Colorado
city: Denver
country: United States
facility: Radiant Research, Inc.
state: Colorado
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Edwardsville
country: United States
facility: Cunningham Clinical Research, LLC
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Midwest Center for Neurobiological Medicine
state: Illinois
city: Rockville
country: United States
facility: Capital Clinical Research Associates
state: Maryland
city: Okemos
country: United States
facility: Summit Research Network (Michigan), Inc.
state: Michigan
city: Clementon
country: United States
facility: CNS Research Institute
state: New Jersey
city: Moorestown
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: New York
country: United States
facility: Eastside Comprehensive Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates, Inc.
state: North Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Bellaire
country: United States
facility: Claghorn-Lesem Research Clinic
state: Texas
city: San Antonio
country: United States
facility: Croft Group Research Center
state: Texas
city: Midlothian
country: United States
facility: Dominion Clinical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle), LLC
state: Washington
Study officials:
References: