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 placeboAdverse 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
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