Escitalopram (Lexapro) for Depression MS or ALS
The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major depressive disorder in patients who have ALS or MS.
Amyotrophic Lateral Sclerosis
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis|
- Hamilton Depression Scale (HAM-D 17). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]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.
- McGill Quality of Life Scale (MQOL) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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).
|Study Start Date:||July 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
All patients will receive escitalopram 20 mg daily.
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.
Other Name: Lexapro
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.
|United States, South Carolina|
|University of South Carolina School of Medicine|
|Columbia,, South Carolina, United States, 20203|
|Principal Investigator:||Meera Narasimhan, MD||University of South Carolina School of Medicine|