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The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00151294
First Posted: September 8, 2005
Last Update Posted: September 14, 2006
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.
Collaborator:
Forest Laboratories
Information provided by:
Weill Medical College of Cornell University
  Purpose
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 Intervention Phase
Depression Multiple Sclerosis Drug: escitalopram oxalate antidepressant Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

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

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

Estimated Enrollment: 20
Study Start Date: November 2004
Estimated Study Completion Date: October 2006
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.
  Eligibility

Information from the National Library of Medicine

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

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 -
  Contacts and Locations
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): NCT00151294


Locations
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
Investigators
Principal Investigator: Barnett S Meyers, MD Weill Medical College of Cornell University
  More Information

ClinicalTrials.gov Identifier: NCT00151294     History of Changes
Other Study ID Numbers: LXP-MD 45
0410007546
First Submitted: September 6, 2005
First Posted: September 8, 2005
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:
Depression
Depressive Disorder
Sclerosis
Multiple Sclerosis
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
Citalopram
Dexetimide
Psychotropic Drugs
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents


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