Clinical trial NCT00042211: Preventing Depression in Patients With Macular Degeneration
Official title: Preventing Depression in Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Macular Degeneration
Keywords: Depressive Disorder
Blindness
Aged
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-07-26
Enrollment: 206
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Depression
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: barry rovner, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rovner BW, Casten RJ. Activity loss and depression in age-related macular degeneration. Am J Geriatr Psychiatry. 2002 May-Jun;10(3):305-10.
citation: Rovner BW, Casten RJ. Neuroticism predicts depression and disability in age-related macular degeneration. J Am Geriatr Soc. 2001 Aug;49(8):1097-100. doi: 10.1046/j.1532-5415.2001.49215.x.
citation: Rovner BW, Ganguli M. Depression and disability associated with impaired vision: the MoVies Project. J Am Geriatr Soc. 1998 May;46(5):617-9. doi: 10.1111/j.1532-5415.1998.tb01080.x.
citation: 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. doi: 10.1001/archopht.120.8.1041.
citation: Tasman W, Rovner B. Age-related macular degeneration: treating the whole patient. Arch Ophthalmol. 2004 Apr;122(4):648-9. doi: 10.1001/archopht.122.4.648. No abstract available.
citation: Casten RJ, Rovner BW, Tasman W. Age-related macular degeneration and depression: a review of recent research. Curr Opin Ophthalmol. 2004 Jun;15(3):181-3. doi: 10.1097/01.icu.0000120710.35941.3f.
citation: 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
citation: Rovner BW, Casten R. Stability of visual acuity measurement in depression. Am J Geriatr Psychiatry. 2005 Mar;13(3):255-8. doi: 10.1176/appi.ajgp.13.3.255.
citation: 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. doi: 10.1001/archpsyc.64.8.886.