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The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00151294
Recruitment Status : Terminated
First Posted : September 8, 2005
Last Update Posted : September 14, 2006
Forest Laboratories
Information provided by:
Weill Medical College of Cornell University

Brief Summary:
Emotionally labile, depressed participants with multiple sclerosis treated with escitalopram will have a greater reduction in emotional lability scores and in their psychological distress scores than those who are randomized to receive placebo.

Condition or disease Intervention/treatment Phase
Depression Multiple Sclerosis Drug: escitalopram oxalate antidepressant Phase 4

Detailed Description:
Patients with multiple sclerosis who are experiencing mood lability and symptoms of depression will be randomized to receive either escitalopram 10mg/day or placebo tablets for a period of 6 weeks. It is hypothesized that patients receiving medication will experience a greater normalization of their emotional instability and a greater reduction in their depressive symptoms at the end of the six-week trial than those who are not receiving medication.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis
Study Start Date : November 2004
Study Completion Date : October 2006

Primary Outcome Measures :
  1. Escitalopram-treated MS patients will have greater reductions in their depressive symptom scores than patients randomized to placebo
  2. Adverse events for both groups will be similar

Secondary Outcome Measures :
  1. Escitalopram-treated emotionally labile patients with MS will have a greater reduction in emotional lability scores than those randomized to placebo.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of multiple sclerosis
  • Having mild to moderate depressive symptoms, with or without emotional lability
  • Experiencing psychological distress

Exclusion Criteria:

  • Meeting DSM-IV diagnostic criteria for Major Depressive Disorder or another Axis 1 diagnosis
  • Cognitive impairment
  • The presence of an unstable medical illness that might preclude completion of the study -

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 identifier (NCT number): NCT00151294

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United States, New York
NewYork Presbyterian Hospital
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
Forest Laboratories
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Principal Investigator: Barnett S Meyers, MD Weill Medical College of Cornell University
Layout table for additonal information Identifier: NCT00151294    
Other Study ID Numbers: LXP-MD 45
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 14, 2006
Last Verified: September 2006
Keywords provided by Weill Medical College of Cornell University:
Depression (mild to moderate)
Affective symptoms
Emotional lability
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antidepressive Agents
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
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents