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Escitalopram (Lexapro) for Depression MS or ALS

Primary Purpose

Major Depression, Multiple Sclerosis, Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
escitalopram
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Amyotrophic Lateral Sclerosis, ALS, Multiple Sclerosis, MS, Major Depression, Depression, Major Depressive Disorder, antidepressants, Escitalopram, Lexapro

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South Carolina School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Escitalopram

Arm Description

All patients will receive escitalopram 20 mg daily.

Outcomes

Primary Outcome Measures

Hamilton Depression Scale (HAM-D 17).
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.

Secondary Outcome Measures

McGill Quality of Life Scale (MQOL)
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).

Full Information

First Posted
August 7, 2009
Last Updated
April 17, 2019
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00965497
Brief Title
Escitalopram (Lexapro) for Depression MS or ALS
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 Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Multiple Sclerosis, Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, ALS, Multiple Sclerosis, MS, Major Depression, Depression, Major Depressive Disorder, antidepressants, Escitalopram, Lexapro

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
All patients will receive escitalopram 20 mg daily.
Intervention Type
Drug
Intervention Name(s)
escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D 17).
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
Secondary Outcome Measure Information:
Title
McGill Quality of Life Scale (MQOL)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meera Narasimhan, MD
Organizational Affiliation
University of South Carolina School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina School of Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
20203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7582177
Citation
Cohen SR, Mount BM, Strobel MG, Bui F. The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med. 1995 Jul;9(3):207-19. doi: 10.1177/026921639500900306.
Results Reference
background
PubMed Identifier
10227631
Citation
Ganzini L, Johnston WS, Hoffman WF. Correlates of suffering in amyotrophic lateral sclerosis. Neurology. 1999 Apr 22;52(7):1434-40. doi: 10.1212/wnl.52.7.1434.
Results Reference
background

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Escitalopram (Lexapro) for Depression MS or ALS

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