Clinical trial NCT00668525: Escitalopram in Adult Patients With Major Depressive Disorder
Official title: A Double-blind, Fixed-dose Study of Escitalopram 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: 2008-04-29
Enrollment: 877
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.
timeFrame: Change from baseline in MADRS total score at week 8
Secondary outcomes:
measure: Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8
timeFrame: Change from baseline in HAM-D at week 8
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Forest Investigative Site
state: Arizona
city: Arcadia
country: United States
facility: Forest Investigative Site
state: California
city: Encino
country: United States
facility: Forest Investigative Site
state: California
city: Garden Grove
country: United States
facility: Forest Investigative Site
state: California
city: Irvine
country: United States
facility: Forest Investigative Site
state: California
city: Los Alamitos
country: United States
facility: Forest Investigative Site
state: California
city: Denver
country: United States
facility: Forest Investigative Site
state: Colorado
city: Washington
country: United States
facility: Forest Investigative Site
state: District of Columbia
city: Bradenton
country: United States
facility: Forest Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site
state: Georgia
city: Newton
country: United States
facility: Forest Investigative Site
state: Kansas
city: Overland
country: United States
facility: Forest Investigative Site
state: Kansas
city: Baltimore
country: United States
facility: Forest Investigative Site
state: Maryland
city: Glen Burnie
country: United States
facility: Forest Investigative Site
state: Maryland
city: Rockville
country: United States
facility: Forest Investigative Site
state: Maryland
city: Okemos
country: United States
facility: Forest Investigative Site
state: Michigan
city: St. Louis
country: United States
facility: Forest Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Forest Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Forest Investigative Site
state: Nebraska
city: Cherry Hill
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Clementon
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Bronx
country: United States
facility: Forest Investigative Site
state: New York
city: Brooklyn
country: United States
facility: Forest Investigative Site
state: New York
city: New York
country: United States
facility: Forest Investigative Site
state: New York
city: New York
country: United States
facility: Forest Investigative Site
state: New York
city: Staten Island
country: United States
facility: Forest Investigative Site
state: New York
city: Canton
country: United States
facility: Forest Investigative Site
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site
state: Ohio
city: Portland
country: United States
facility: Forest Investigative Site
state: Oregon
city: Media
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Memphis
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Forest Investigative Site
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Forest Investigative Site
state: Utah
city: Woodstock
country: United States
facility: Forest Investigative Site
state: Vermont
city: Richmond
country: United States
facility: Forest Investigative Site
state: Virginia
city: Bellevue
country: United States
facility: Forest Investigative Site
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site
state: Washington
Study officials:
affiliation: Forest Laboratories
name: Carl Gommoll, MS
role: STUDY_DIRECTOR
References: