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

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ClinicalTrials.gov Identifier: NCT00384436
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : January 7, 2008
Sponsor:
Information provided by:
Forest Laboratories

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: escitalopram Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients
Study Start Date : October 2006
Actual Primary Completion Date : October 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Time to premature discontinuation

Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale (MADRS)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384436


Locations
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United States, Missouri
For information regarding investigative sites, contact Forest Professional Affairs
St Louis, Missouri, United States, 63045
Sponsors and Collaborators
Forest Laboratories

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00384436     History of Changes
Other Study ID Numbers: SCT-MD-39
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: January 7, 2008
Last Verified: January 2008

Keywords provided by Forest Laboratories:
Major Depressive Disorder

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents