Study of Escitalopram (Lexapro) for Improvement of Depressive Symptoms and Quality of Life in People With Multiple Sclerosis (MS) or Amyotrophic Lateral Sclerosis (ALS) Who Are Experiencing Depression
Information source: University of South Carolina
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression; Multiple Sclerosis; Amyotrophic Lateral Sclerosis
Intervention: escitalopram (Lexapro) (Drug)
Phase: Phase 3
Status: Recruiting
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
Overall contact:
Suzanne M Hardeman, MRC, MSN, Phone: 803-434-3622, Email: shardeman@uscmed.sc.edu
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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Improvement in depressive symptoms as assessed by change from baseline to eight weeks scores on Hamilton Depression Scale (HAM-D 17).
Secondary outcome: Changes in scores on CGI-I , CGI-S, BDI-II, BAI, McGill Quality of Life Scale, , Edmonton Symptom Assessment System, ALS Functional Rating Scale (ALS only) Expanded Disability Status Scale (MS only) from baseline to end of treatment.
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
Suzanne M Hardeman, MRC, MSN, Phone: 803-434-3622, Email: shardeman@uscmed.sc.edu
University of South Carolina School of Medicine, Columbia,, South Carolina 20203, United States; Recruiting
Shilpa Srinivasan, MD, Sub-Investigator
Davit Mrelashvili, MD, Sub-Investigator
Suzanne M Hardeman, MSN, MRC, Sub-Investigator
Meera Narasimhan, MD, Principal Investigator
Additional Information
Click here for more information about this study....Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) and Depression
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
Ending date: March 2010
Last updated: August 24, 2009
|
