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DepressionPhase 3NCT00042211

Preventing Depression in Patients With Macular Degeneration

A Phase 3 study testing Problem Solving Treatment in people with Depression and Macular Degeneration, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Depression, Macular Degeneration
What is being tested?
Problem Solving Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
1 siteUnited States
Study dates
Feb 2001to Jan 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Bilateral macular degeneration
  • Visual acuity of 20/40 or worse in better eye
  • Residence within 40 miles of Wills Eye Hospital in Philadelphia, PA

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Preventing Depression in 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).

Read the 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.

Being tested
Problem Solving Treatment, Control
Keywords
Depressive Disorder, Blindness, Aged
Medical subject headings
Depression, Macular Degeneration, Depressive Disorder, Blindness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Problem Solving TreatmentBehavioural

    Brief Cognitive Behavioral Therapy

  • ControlBehavioural

    No treatment control

Study groups in NCT00042211
Study groupRoleWhat they receive
1ExperimentalProblem Solving Treatment
Receives: Behavioral: Problem Solving Treatment
2Active comparatorControl
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2002 (estimated)
  2. Study startFeb 2001
  3. Primary completionJan 2006
  4. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00042211
Sponsor's protocol ID
R01MH061331
Other IDs
R01MH061331, DATR A4-GPS
Status last verified
Feb 2008
First submitted
24 Jul 2002
Last updated
8 Jan 2014
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 11994218

  • 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.

    PubMed 11555073

  • 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.

    PubMed 9588377

  • Rovner, B.W., Casten, R.J., & Tasman, W.S. (in press). Depression impairs visionfunction in age-related macular degeneration.Archives of Ophthalmology.

  • 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.

    PubMed 12149057

  • 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.

    PubMed 15078685

  • 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.

    PubMed 15118503

  • 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 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.

    PubMed 15728758

  • 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.

    PubMed 17679633

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Problem Solving Treatment in people with Depression and Macular Degeneration, run by Thomas Jefferson University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00042211, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2014.

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