Clinical trial NCT00108979: Study of Escitalopram in Adult Patients With Major Depressive Disorder
Official title: Double-Blind 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: 2005-04-22
Enrollment: 240
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, safety, and pharmacoeconomics of escitalopram and an active comparator 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: Okemos
country: United States
facility: Summit Research Network
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Philadelphia
country: United States
facility: CNS Research Institute
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions
state: Tennessee
city: Salt Lake City
country: United States
facility: Radiant Research
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network
state: Washington
Study officials:
References:
citation: 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.