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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.
 
ClinicalTrials.gov Identifier: NCT00151294
Recruitment Status : Terminated
First Posted : September 8, 2005
Last Update Posted : September 14, 2006
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE September 6, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date September 14, 2006
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00151294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
Escitalopram-treated emotionally labile patients with MS will have a greater reduction in emotional lability scores than those randomized to placebo.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis
Official Title  ICMJE A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Multiple Sclerosis
Intervention  ICMJE Drug: escitalopram oxalate antidepressant
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: September 7, 2005)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151294
Other Study ID Numbers  ICMJE LXP-MD 45
0410007546
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Barnett S Meyers, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP