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The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

Information source: Weill Medical College of Cornell University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression; Multiple Sclerosis

Intervention: escitalopram oxalate antidepressant (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
Barnett S Meyers, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell University

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.

Clinical Details

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

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

Primary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 -

Locations and Contacts

NewYork Presbyterian Hospital, White Plains, New York 10605, United States
Additional Information

Starting date: November 2004
Last updated: September 12, 2006

Page last updated: August 20, 2015

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