Escitalopram (Lexapro) for Depression MS or ALS

This study has been completed.

Study NCT00965497 Information provided by University of South Carolina

First Received on August 7, 2009. Last Updated on August 4, 2011 History of Changes

Results First Received: April 19, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Major Depression Multiple Sclerosis Amyotrophic Lateral Sclerosis
Intervention:	Drug: escitalopram

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited through local neurology groups and ALS and MS support groups. No subjects with ALS were recruited.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Open-label, Single Arm	All patients will receive the intervention

Participant Flow: Overall Study

	Open-label, Single Arm
STARTED	14
COMPLETED	13
NOT COMPLETED	1
Physician Decision	1

Baseline Characteristics

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Reporting Groups

	Description
Open-label, Single Arm	All patients will receive the intervention

Baseline Measures

	Open-label, Single Arm
Number of Participants [units: participants]	14
Age [units: participants]
<=18 years	0
Between 18 and 65 years	14
>=65 years	0
Gender [units: participants]
Female	12
Male	2
Region of Enrollment [units: participants]
United States	14

Outcome Measures

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1. Primary:

Hamilton Depression Scale (HAM-D 17). [ Time Frame: 8 weeks ]

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2. Secondary:

McGill Quality of Life Scale (MQOL) [ Time Frame: 8 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Meera Narasimhan, MD
Organization: University of South Carolina School of Medicine
phone: 803-434-1100
e-mail: shardeman@uscmed.sc.edu

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