NCT00151294

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 depression

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

September 14, 2006

Status Verified

September 1, 2006

First QC Date

September 6, 2005

Last Update Submit

September 12, 2006

Conditions

DepressionMultiple Sclerosis

Keywords

Depression (mild to moderate)Affective symptomsEmotional labilityMultiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

Interventions

escitalopram oxalate antidepressantDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of multiple sclerosis
  • Having mild to moderate depressive symptoms, with or without emotional lability
  • Experiencing psychological distress

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NewYork Presbyterian Hospital

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

DepressionMultiple SclerosisAffective Symptoms

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Barnett S Meyers, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

November 1, 2004

Study Completion

October 1, 2006

Last Updated

September 14, 2006

Record last verified: 2006-09

Locations

US(1)