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The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

Primary Purpose

Depression, Multiple Sclerosis

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

escitalopram oxalate antidepressant

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression (mild to moderate), Affective symptoms, Emotional lability, Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

NewYork Presbyterian Hospital

Outcomes

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.

Full Information

NCT ID

NCT00151294

First Posted

September 6, 2005

Last Updated

September 12, 2006

Sponsor

Weill Medical College of Cornell University

Collaborators

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00151294

Brief Title

The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

Official Title

A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Terminated

Study Start Date

November 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

Forest Laboratories

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Multiple Sclerosis

Keywords

Depression (mild to moderate), Affective symptoms, Emotional lability, Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

escitalopram oxalate antidepressant

Primary Outcome Measure Information:

Title

Escitalopram-treated MS patients will have greater reductions in their depressive symptom scores than patients randomized to placebo

Title

Adverse events for both groups will be similar

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barnett S Meyers, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

NewYork Presbyterian Hospital

City

White Plains

State/Province

New York

ZIP/Postal Code

10605

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

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