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Completed

NCT Number: NCT00042211

Preventing Depression in Patients With Macular Degeneration

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms Blindness Depressive Disorder Eye Diseases Macular Degeneration Mental Disorders Mood Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Sensation Disorders Signs and Symptoms Vision Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Problem Solving Treatment

Behavioral

Brief Cognitive Behavioral Therapy

Control

Behavioral

No treatment control

Primary outcomes

  1. Depression

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Preventing Depression in Macular Degeneration

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Jul 26, 2002
Registry last updated
Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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