Treatment for Post-Stroke Depression

This study has been completed.

Study NCT00029172 Information provided by Indiana University

First Received on January 8, 2002. Last Updated on December 31, 2009 History of Changes

Results First Received: August 3, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Stroke Depression
Intervention:	Other: case management

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
Subjects were recruited from 4 Indianapolis based hospitals. Depression enrollment and screening occurred between 1 and 2 months post stroke.

Pre-Assignment Details

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

	Description
Case Management	No text entered.

Participant Flow: Overall Study

	Case Management
STARTED	188
COMPLETED	182
NOT COMPLETED	6

Baseline Characteristics

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Reporting Groups

	Description
Case Management	No text entered.

Baseline Measures

	Case Management
Number of Participants [units: participants]	182
Age [units: years] Mean ± Standard Deviation	61 ± 3
Gender [units: participants]
Female	99
Male	83
Region of Enrollment [units: participants]
United States	182

Outcome Measures

1. Primary:

Twelve Week Depression Outcomes [ Time Frame: Twelve week ]

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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: Dr. Linda Williams
Organization: Roudebush VAMC Center of Excellence
phone: 317-988-3337
e-mail: linda.williams6@va.gov

Publications of Results:

Williams LS, Kroenke K, Bakas T, Plue LD, Brizendine E, Tu W, Hendrie H. Care management of poststroke depression: a randomized, controlled trial. Stroke. 2007 Mar;38(3):998--1003.

Other Publications:

Williams LS, Brizendine EJ, Plue L, Bakas T, Tu W, Hendrie H, Kroenke K. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke. 2005 Mar;36(3):635-8. Epub 2005 Jan 27.

Williams LS, Bakas T, Brizendine E, Plue L, Tu W, Hendrie H, Kroenke K. How valid are family proxy assessments of stroke patients' health-related quality of life? Stroke. 2006 Aug;37(8):2081-5. Epub 2006 Jun 29.

Responsible Party:	Linda Williams, M.D., Roudebush VA Medical Center
ClinicalTrials.gov Identifier:	NCT00029172 History of Changes
Other Study ID Numbers:	9903-06
Study First Received:	January 8, 2002
Results First Received:	August 3, 2009
Last Updated:	December 31, 2009
Health Authority:	United States: Federal Government