Preventing Depression in Patients With Macular Degeneration

This study has been completed.

Sponsor:

Information provided by:

National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier:

NCT00042211

First received: July 24, 2002

Last updated: February 12, 2008

Last verified: February 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	July 24, 2002
Last Updated Date	February 12, 2008
Start Date ^ICMJE	February 2001
Primary Completion Date	January 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 12, 2008)	Depression [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00042211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Preventing Depression in Patients With Macular Degeneration
Official Title ^ICMJE	Preventing Depression in Macular Degeneration
Brief Summary	This study will evaluate the effectiveness of a Problem Solving Treatment in preventing depression in elderly patients with age-related macular degeneration (AMD).
Detailed Description	AMD is the most common cause of blindness in older adults. The disease limits the ability to read, see familiar faces, and walk independently. Almost 2 million persons (about 5 percent of the U.S. population over age 65) are now affected, and this number will triple by the year 2020. This study will target patients with neovascular AMD (NV-AMD), a form of AMD which can lead to sudden vision loss, substantial disability, and depression. Because depression is itself disabling and not likely to be recognized nor treated by ophthalmologists, preventing depression in people with NV-AMD is important. Patients are randomly assigned to either PST or a usual care control condition. The primary outcome measure is a DSM-IV diagnosis of depression. Patients are evaluated at baseline, Month 2 (immediately post-intervention), Month 6 (for the primary efficacy analysis), and Month 12 (to evaluate sustained effects). The study will also assess the impact of PST on levels of disability and vision-related quality of life.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Depression Macular Degeneration
Intervention ^ICMJE	Behavioral: Problem Solving Treatment Brief Cognitive Behavioral Therapy Behavioral: Control No treatment control
Study Arm (s)	Experimental: 1 Problem Solving Treatment Intervention: Behavioral: Problem Solving Treatment Active Comparator: 2 Control Intervention: Behavioral: Control
Publications *	Rovner BW, Casten RJ. Activity loss and depression in age-related macular degeneration. Am J Geriatr Psychiatry. 2002 May-Jun;10(3):305-10. Rovner BW, Casten RJ. Neuroticism predicts depression and disability in age-related macular degeneration. J Am Geriatr Soc. 2001 Aug;49(8):1097-100. Rovner BW, Ganguli M. Depression and disability associated with impaired vision: the MoVies Project. J Am Geriatr Soc. 1998 May;46(5):617-9. Rovner BW, Casten RJ, Tasman WS. Effect of depression on vision function in age-related macular degeneration. Arch Ophthalmol. 2002 Aug; 120(8): 1041-4. Tasman, W., & Rovner, B. W. (in press). Age related macular degeneration: reating the whole person. Archives in Ophthalmology Casten, R. J., Rovner, B. W., & Tasmas, W. (in press). Age related macular degeneration and depression: a review of recent research. Current Opinions in Ophthalmololgy. Casten, R. J., & Rovner, B. W. The role of psychological characteristics in the use and perceived importance of low vision aids. Submitted to the Journal of Vision Impairment and Blindness Rovner, B. W., & Casten, R. J. Stability of Visual Acuity Measurement in Depression. Submitted to the Archives of Ophthalmology. Rovner BW, Casten RJ, Hegel MT, Leiby BE, Tasman WS. Preventing depression in age-related macular degeneration. Arch Gen Psychiatry. 2007 Aug;64(8):886-92.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	206
Completion Date	January 2006
Primary Completion Date	January 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion criteria: Bilateral macular degeneration Visual acuity of 20/40 or worse in better eye Residence within 40 miles of Wills Eye Hospital in Philadelphia, PA
Gender	Both
Ages	65 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00042211
Other Study ID Numbers ^ICMJE	R01 MH61331, DATR A4-GPS
Has Data Monitoring Committee	Not Provided
Responsible Party	Barry Rovner, MD, Thomas Jefferson University
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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