Escitalopram (Lexapro) for Depression MS or ALS - Full Text View

Sponsor:	University of South Carolina
Information provided by:	University of South Carolina
ClinicalTrials.gov Identifier:	NCT00965497

Purpose

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	Intervention	Phase
Major Depression Multiple Sclerosis Amyotrophic Lateral Sclerosis	Drug: escitalopram	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Depression Multiple Sclerosis

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by University of South Carolina:

Primary Outcome Measures:

Hamilton Depression Scale (HAM-D 17). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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).

Enrollment:	13
Study Start Date:	July 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965497

Locations

United States, South Carolina
University of South Carolina School of Medicine
Columbia,, South Carolina, United States, 20203

Sponsors and Collaborators

University of South Carolina

Investigators

Principal Investigator:

Meera Narasimhan, MD

University of South Carolina School of Medicine

More Information

Additional Information:

Click here for more information about this study....Amyotrophic Lateral Sclerosis (ALS) or Multiple Sclerosis (MS) and Depression This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

Ganzini L, Johnston WS, Hoffman WF. Correlates of suffering in amyotrophic lateral sclerosis. Neurology. 1999 Apr 22;52(7):1434-40.

Responsible Party:	Meera Narasimhan, MD, University of South Carolina School of Medicine
ClinicalTrials.gov Identifier:	NCT00965497 History of Changes
Other Study ID Numbers:	LXP-113
Study First Received:	August 7, 2009
Results First Received:	April 19, 2011
Last Updated:	August 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of South Carolina:

Amyotrophic Lateral Sclerosis
ALS
Multiple Sclerosis
MS
Major Depression

Depression
Major Depressive Disorder
antidepressants
Escitalopram
Lexapro

Additional relevant MeSH terms:

Amyotrophic Lateral Sclerosis
Depression
Depressive Disorder
Multiple Sclerosis
Sclerosis
Depressive Disorder, Major
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases

Behavioral Symptoms
Mood Disorders
Mental Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012