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

Tracking Information
First Submitted Date  ICMJE August 7, 2009
First Posted Date  ICMJE August 25, 2009
Results First Submitted Date  ICMJE April 19, 2011
Results First Posted Date  ICMJE September 7, 2011
Last Update Posted Date May 1, 2019
Study Start Date  ICMJE July 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Escitalopram (Lexapro) for Depression MS or ALS
Official Title  ICMJE An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depression
  • Multiple Sclerosis
  • Amyotrophic Lateral Sclerosis
Intervention  ICMJE Drug: escitalopram
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
Study Arms  ICMJE Experimental: Escitalopram
All patients will receive escitalopram 20 mg daily.
Intervention: Drug: escitalopram
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2011)
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2009)
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00965497
Other Study ID Numbers  ICMJE Pro00003013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meera Narasimhan, University of South Carolina
Study Sponsor  ICMJE University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Meera Narasimhan, MD University of South Carolina School of Medicine
PRS Account University of South Carolina
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP