The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00151294
• Other study ID #: LXP-MD 45
• Secondary ID: 0410007546
• Status: Terminated
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: September 12, 2006
• Start date: November 2004
• Est. completion date: October 2006

Study information

• Verified date: September 2006
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• escitalopram oxalate antidepressant

Locations

Country	Name	City	State
United States	NewYork Presbyterian Hospital	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Escitalopram-treated MS patients will have greater reductions in their depressive symptom scores than patients randomized to placebo
Primary	Adverse events for both groups will be similar
Secondary	Escitalopram-treated emotionally labile patients with MS will have a greater reduction in emotional lability scores than those randomized to placebo.