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

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2010

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.

Intervention(s) in this Clinical Trial

• Drug: escitalopram (Lexapro)
  • After confirmation of diagnoses and safety screening escitalopram will be started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day. The dose will be titrated upward or downward based on clinical response and tolerability. No other psychotropic medications will be permitted during the study. Medications for coexisting medical problems (e.g. hypertension) will be permitted. Study visits will include weekly visits for first 2 weeks and biweekly visits for next 6 weeks. Medications will be dispensed weekly or biweekly and the participants will be followed for 8 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Open-label, single arm
  • All patients will receive the intervention

Primary Measures

• Improvement in depressive symptoms as assessed by change from baseline to eight weeks scores on Hamilton Depression Scale (HAM-D 17).
  • Time Frame: 2-8 weeks
    Safety Issue?: Yes

Secondary Measures

• 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.
  • Time Frame: 2-8 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of South Carolina

Overall Clinical Trial Officials and Contacts

Meera Narasimhan, MD Principal Investigator University of South Carolina School of Medicine  

Overall Contact: Suzanne M Hardeman, MRC, MSN 803-434-3622 shardeman@uscmed.sc.edu

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00965497

Study ID Number: LXP-113

ClinicalTrials.gov Identifier: NCT00965497

Health Authority: United States: Institutional Review Board

Click here for more information about this study....Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) and Depression