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CompletedNCT00108979Updated Mar 5, 2012

Study of Escitalopram in Adult Patients With Major Depressive Disorder

A Phase 3 interventional study of Escitalopram in Major Depressive Disorder, sponsored by Forest Laboratories. Completed at 9 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-03-05.

Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

  • Major Depressive Disorder

Keywords

  • Depression
  • Major Depressive Disorder
  • Escitalopram
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In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 240 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
240 participants

Interventions

  • DrugEscitalopram
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What researchers measure

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale (MADRS)

Secondary outcomes

  1. Hamilton Depression Rating Scale (HAMD)

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Study locations

9 sites
  • Southwest Health, Ltd.
    Phoenix, Arizona 85016, United States
  • Summit Research Network
    Okemos, Michigan 48864, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • Summit Research Network
    Portland, Oregon 97210, United States
  • CNS Research Institute
    Philadelphia, Pennsylvania 19149, United States
  • Clinical Neuroscience Solutions
    Memphis, Tennessee 38119, United States
  • Radiant Research
    Salt Lake City, Utah 84107, United States
  • Northwest Clinical Research Center
    Bellevue, Washington 98004, United States
  • Summit Research Network
    Seattle, Washington 98104, United States
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References and documents

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. Erratum In: Curr Med Res Opin. 2011 Sep;27(9):1708. PubMed 21438794 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00108979
Lead sponsor
Forest Laboratories
First posted
Apr 22, 2005
Start date
Mar 2005
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Mar 5, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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