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Preventing Depression in Patients With Macular Degeneration

Preventing Depression in Macular Degeneration

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00042211
Enrollment
206
Registered
2002-07-26
Start date
2001-02-28
Completion date
2006-01-31
Last updated
2014-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Macular Degeneration

Keywords

Depressive Disorder, Blindness, Aged

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.

Interventions

Brief Cognitive Behavioral Therapy

BEHAVIORALControl

No treatment control

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Depression6 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026