Preventing Depression in Patients With Macular Degeneration

Depression Clinical Trial

Official title:

Preventing Depression in Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042211
• Other study ID #: R01MH061331
• Secondary ID: R01MH061331DATR
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2002
• Last updated: January 7, 2014
• Start date: February 2001
• Est. completion date: January 2006

Study information

• Verified date: February 2008
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Macular Degeneration

Intervention

Behavioral:
• Problem Solving Treatment
Brief Cognitive Behavioral Therapy
• Control
No treatment control

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Review. — View 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

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. — View 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. — View 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. — View 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. — View Citation

Rovner, B. W., & Casten, R. J. Stability of Visual Acuity Measurement in Depression. Submitted to the Archives of Ophthalmology.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression		6 Months	No