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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

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.

Condition or disease Intervention/treatment Phase
Major Depression Multiple Sclerosis Amyotrophic Lateral Sclerosis Drug: escitalopram Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: Escitalopram
All patients will receive escitalopram 20 mg daily.
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00965497

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United States, South Carolina
University of South Carolina School of Medicine
Columbia, South Carolina, United States, 20203
Sponsors and Collaborators
University of South Carolina
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Principal Investigator: Meera Narasimhan, MD University of South Carolina School of Medicine
Additional Information:
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Responsible Party: Meera Narasimhan, Professor, University of South Carolina Identifier: NCT00965497    
Other Study ID Numbers: Pro00003013
First Posted: August 25, 2009    Key Record Dates
Results First Posted: September 7, 2011
Last Update Posted: May 1, 2019
Last Verified: August 2011
Keywords provided by Meera Narasimhan, University of South Carolina:
Amyotrophic Lateral Sclerosis
Multiple Sclerosis
Major Depression
Major Depressive Disorder
Additional relevant MeSH terms:
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Multiple Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents