The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

September 12, 2006

Start Date ^ICMJE

November 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

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

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Depression
Multiple Sclerosis

Intervention ^ICMJE

Drug: escitalopram oxalate antidepressant

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

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 -

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00151294

Responsible Party

Study ID Numbers ^ICMJE

LXP-MD 45, 0410007546

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

Information Provided By

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