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Escitalopram (Lexapro) for Depression MS or ALS

Information source: University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depression; Multiple Sclerosis; Amyotrophic Lateral Sclerosis

Intervention: escitalopram (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of South Carolina

Official(s) and/or principal investigator(s):
Meera Narasimhan, MD, Principal Investigator, Affiliation: University of South Carolina School of Medicine

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Hamilton Depression Scale (HAM-D 17).

Secondary outcome: McGill Quality of Life Scale (MQOL)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

University of South Carolina School of Medicine, Columbia,, South Carolina 20203, United States
Additional Information

Related publications:

Cohen SR, Mount BM, Strobel MG, Bui F. The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med. 1995 Jul;9(3):207-19.

Ganzini L, Johnston WS, Hoffman WF. Correlates of suffering in amyotrophic lateral sclerosis. Neurology. 1999 Apr 22;52(7):1434-40.

Starting date: July 2009
Last updated: August 4, 2011

Page last updated: August 23, 2015

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