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The Efficacy and Safety of Escitalopram for Depression in Multiple Sclerosis

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00151294
Enrollment
20
Registered
2005-09-08
Start date
2004-11-30
Completion date
2006-10-31
Last updated
2006-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Multiple Sclerosis

Keywords

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

Brief 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.

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.

Interventions

DRUGescitalopram oxalate antidepressant

Sponsors

Forest Laboratories
CollaboratorINDUSTRY
Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026