The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

NCT ID: NCT00151294

Last Updated: 2006-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Depression Multiple Sclerosis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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escitalopram oxalate antidepressant

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Principal Investigators

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Barnett S Meyers, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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NewYork Presbyterian Hospital

White Plains, New York, United States

Site Status

Countries

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United States

Other Identifiers

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0410007546

Identifier Type: -

Identifier Source: secondary_id

LXP-MD 45

Identifier Type: -

Identifier Source: org_study_id