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OpenTrials
Completed

NCT Number: NCT00384436

Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients

The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

For information regarding investigative sites, contact Forest Professional Affairs

St Louis, Missouri, 63045, United States

About this study

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 safety and efficacy of escitalopram and an active comparator in severely depressed patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must meet DSM-IV criteria for Major Depressive Disorder.
  • Patients must have severe depression.
  • MADRS greater than or equal to 30

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 are considered a suicide risk.
  • Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia.
  • Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder.
  • Patients with history of any psychotic disorder or any psychotic feature.

Treatment and study plan

Escitalopram

Drug

Primary outcomes

  1. Time to premature discontinuation

Secondary outcomes

  1. Montgomery Asberg Depression Rating Scale (MADRS)

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Important dates

Study start
2006
Primary completion
2007
First posted
Oct 6, 2006
Registry last updated
Jan 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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