Escitalopram (Lexapro) for Depression MS or ALS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00965497|
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : September 7, 2011
Last Update Posted : September 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Major Depression Multiple Sclerosis Amyotrophic Lateral Sclerosis||Drug: escitalopram||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2009|
|Primary Completion Date :||March 2010|
|Study Completion Date :||March 2010|
U.S. FDA Resources
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
- Hamilton Depression Scale (HAM-D 17). [ Time Frame: 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.
- McGill Quality of Life Scale (MQOL) [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965497
|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|