An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis

University of South Carolina1 site in 1 country13 target enrollmentJuly 2009

ConditionsMajor Depression Multiple Sclerosis Amyotrophic Lateral Sclerosis

Interventionsescitalopram

Drugsescitalopram

Overview

Phase: Phase 3
Intervention: escitalopram
Conditions: Major Depression
Sponsor: University of South Carolina
Enrollment: 13
Locations: 1
Primary Endpoint: Hamilton Depression Scale (HAM-D 17).
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.

Detailed Description

This eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of Major Depression in patients with Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) as measured by the HAM-D. In addition, the study will assess improvement in the quality of life in patients with Major Depression and ALS or MS.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

March 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of South Carolina

Responsible Party

Principal Investigator

Meera Narasimhan

Professor

University of South Carolina

Eligibility Criteria

Inclusion Criteria

•Patients between 18 and 70 years of age with documented ALS or MS,
•DSM-IV episode of non-psychotic Major Depression,
•≥14 score on the 17-item HAM-D,
•Ability to give informed consent.

Exclusion Criteria

•History of psychotic disorders,
•Psychotic depression,
•Bipolar depression,
•Suicide risk,
•History of substance abuse in the previous 6 months,
•History of unstable medical disorders,
•Pregnancy or planning for pregnancy,
•Severity of ALS or MS that limits participating in the study protocol.

Arms & Interventions

Escitalopram

All patients will receive escitalopram 20 mg daily.

Intervention: escitalopram

Outcomes

Primary Outcomes

Hamilton Depression Scale (HAM-D 17).

Time Frame: 8 weeks

Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.