Expired Study
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White Plains, New York 10605


Purpose:

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.


Study summary:

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.


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 -


Study is Available At:


Original ID:

LXP-MD 45


NCT ID:

NCT00151294


Secondary ID:

0410007546


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Weill Medical College of Cornell University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:


Overall Contact Information

Official Name:Barnett S Meyers, MD
Principal Investigator
Weill Medical College of Cornell University

Study Dates

Start Date:November 2004
Completion Date:October 2006
Verification Date:September 2006
Last Changed Date:September 12, 2006
First Received Date:September 6, 2005

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:escitalopram oxalate antidepressant

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Weill Medical College of Cornell University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Forest Laboratories

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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