Preventing Depression in Patients With Macular Degeneration - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00042211

Purpose

This study will evaluate the effectiveness of a Problem Solving Treatment in preventing depression in elderly patients with age-related macular degeneration (AMD).

Condition	Intervention	Phase
Depression Macular Degeneration	Behavioral: Problem Solving Treatment Behavioral: Control	Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Depression Macular Degeneration

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Preventing Depression in Macular Degeneration

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Depression [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment:	206
Study Start Date:	February 2001
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Problem Solving Treatment	Behavioral: Problem Solving Treatment Brief Cognitive Behavioral Therapy
2: Active Comparator Control	Behavioral: Control No treatment control

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042211

Locations

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

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.

Publications indexed to this study:

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.

Responsible Party:	Thomas Jefferson University ( Barry Rovner, MD )
Study ID Numbers:	R01 MH61331, DATR A4-GPS
Study First Received:	July 24, 2002
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00042211
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Depressive Disorder
Blindness
Aged

Study placed in the following topic categories:

Depression
Mental Disorders
Eye Diseases
Mood Disorders
Retinal Degeneration
Macular Degeneration

Blindness
Depressive Disorder
Retinal Diseases
Retinal degeneration
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 13, 2009