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Escitalopram (Lexapro) for Depression MS or ALS

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ClinicalTrials.gov Identifier: NCT00965497
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : September 7, 2011
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Meera Narasimhan, University of South Carolina

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Major Depression
Multiple Sclerosis
Amyotrophic Lateral Sclerosis
Intervention Drug: escitalopram
Enrollment 13
Recruitment Details Recruited through local neurology groups and ALS and MS support groups. No subjects with ALS were recruited.
Pre-assignment Details Patients switched from another antidepressant to escitalopram were either cross-titrated to escitalopram over 1 week or went through 3 day washout before starting escitalopram. Subjects with uncontrolled medical conditions (i.e., uncontrolled hypertension)were excluded.
Arm/Group Title Open-label, Single Arm
Hide Arm/Group Description All patients will receive the intervention
Period Title: Overall Study
Started 14
Completed 13
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title Open-label, Single Arm
Hide Arm/Group Description All patients will receive the intervention
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
12
  85.7%
Male
2
  14.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Hamilton Depression Scale (HAM-D 17).
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat
Arm/Group Title Escitalopram
Hide Arm/Group Description:
One-arm study of escitalopram 20 mg daily
Overall Number of Participants Analyzed 13
Median (Standard Deviation)
Unit of Measure: depression severity
15  (7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram
Comments There were 13 people that completed so there truly was no power to detect true differences; therefore only trends can be discussed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 95
Estimation Comments [Not Specified]
2.Secondary Outcome
Title McGill Quality of Life Scale (MQOL)
Hide Description 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).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram
Hide Arm/Group Description:
One-arm study of escitalopram 20 mg daily
Overall Number of Participants Analyzed 13
Mean (Full Range)
Unit of Measure: quality of life
5
(0 to 10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-label, Single Arm
Hide Arm/Group Description All patients will receive the intervention
All-Cause Mortality
Open-label, Single Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open-label, Single Arm
Affected / at Risk (%) # Events
Total   0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-label, Single Arm
Affected / at Risk (%) # Events
Total   5/14 (35.71%)    
Gastrointestinal disorders   
Nausea vomiting and diarrhea †  5/14 (35.71%)  5
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Meera Narasimhan, MD
Organization: University of South Carolina School of Medicine
Phone: 803-434-1100
EMail: shardeman@uscmed.sc.edu
Publications:
Layout table for additonal information
Responsible Party: Meera Narasimhan, University of South Carolina
ClinicalTrials.gov Identifier: NCT00965497     History of Changes
Other Study ID Numbers: Pro00003013
First Submitted: August 7, 2009
First Posted: August 25, 2009
Results First Submitted: April 19, 2011
Results First Posted: September 7, 2011
Last Update Posted: May 1, 2019