Escitalopram (Lexapro) for Depression MS or ALS

Phase 3

Completed

• Conditions: Major Depression; Multiple Sclerosis; Amyotrophic Lateral Sclerosis
• Interventions: Drug: escitalopram

• Registration Number: NCT00965497
• Lead Sponsor: University of South Carolina

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-04-19
• Status Verified: 2011-08
• Results First Submitted QC: 2011-08-04
• Results First Posted: 2011-09-07
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Escitalopram	escitalopram	All patients will receive escitalopram 20 mg daily.

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale (HAM-D 17).	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.

Secondary Outcome Measures

Name	Time	Method
McGill Quality of Life Scale (MQOL)	8 weeks	McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent).

Trial Locations

Locations (1)

University of South Carolina School of Medicine; 🇺🇸 Columbia, South Carolina, United States