While advances have been made in the acute treatment of geriatric depression, failure to maintain remission following successful treatment remains a major public health problem. In particular, loss of antidepressant response can result in ongoing functional impairment and increased risk of suicide. This is especially salient for severe and/or treatment resistant illness, even after successful ECT. This competing continuation application builds upon our prior work demonstrating that continuation pharmacotherapy and continuation ECT were equally but only modestly effective over 6 months. These results highlight the need to develop improved strategies to maintain remission and optimize functional outcomes. The current application tests a novel strategy that utilizes pharmacotherapy-enhanced ECT in the acute phase. It then combines the 2 continuation modalities [pharmacotherapy and continuation ECT], and introduces a novel patient-focused individualization of the ECT schedule (Symptom-Titrated, Algorithm-Based Longitudinal ECT (STABLE)) to enhance long-term outcomes in late-life depression. In STABLE, the ECT schedule is clinically driven to prevent over-treatment of those who do not need it, and to permit re-capturing clinical response for those patients who might have otherwise relapsed with a rigid dosing schedule. STABLE combines a fixed ECT taper followed by an individualized, flexible ECT schedule responsive to symptom re-emergence. This approach provides the first operationalized guidance to the field regarding how to conduct continuation ECT. The primary aim of the Prolonging Remission In Depressed Elderly (PRIDE) trial is to compare, in a randomized clinical trial of patients with late-life depression, the relative efficacy, functional outcomes, and tolerability of two strategies to sustain antidepressant effect after successful acute treatment: 1) combination pharmacotherapy with venlafaxine and lithium (PHARM) and 2) the same combination of pharmacotherapy plus symptom-titrated ECT (STABLE). At 7 sites, 322 patients receive an acute course of ECT augmented by standardized medication (Phase 1);188 remitters are randomly assigned to one of the 2 groups and followed for 6 months (Phase 2). The primary outcome measure is the longitudinal continuous Hamilton Rating Scale for Depression (HRSD-24). Secondary outcomes are measures of function and tolerability validated in the geriatric sample. By 2020, depression is predicted to become the 2nd leading cause of disease burden worldwide and a major cause of suicide. Late-life depression is particularly important given the rapid growth of the geriatric segment of the population. Patient-focused approaches will guide the development of targeted strategies to reduce disease burden and to enhance quality of life for older patients with severe mood disorders who are at significant risk for suicide.

Public Health Relevance

Significance statement: By 2020, depression is predicted to become the 2nd leading cause of disease burden worldwide and a major cause of suicide. Late-life depression is particularly important given the rapid growth of the geriatric segment of the population. Patient-focused approaches will guide the development of targeted strategies to reduce disease burden and to enhance quality of life for older patients with severe mood disorders who are at significant risk for suicide.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01MH055495-10
Application #
8053779
Study Section
Interventions Committee for Disorders Related to Schizophrenia, Late Life, or Personality (ITSP)
Program Officer
Evans, Jovier D
Project Start
2009-07-27
Project End
2014-03-31
Budget Start
2011-04-01
Budget End
2012-03-31
Support Year
10
Fiscal Year
2011
Total Cost
$385,277
Indirect Cost
Name
Icahn School of Medicine at Mount Sinai
Department
Psychiatry
Type
Schools of Medicine
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029
McCall, W Vaughn; Lisanby, Sarah H; Rosenquist, Peter B et al. (2018) Effects of continuation electroconvulsive therapy on quality of life in elderly depressed patients: A randomized clinical trial. J Psychiatr Res 97:65-69
McCall, W Vaughn; Lisanby, Sarah H; Rosenquist, Peter B et al. (2017) Effects of a right unilateral ultrabrief pulse electroconvulsive therapy course on health related quality of life in elderly depressed patients. J Affect Disord 209:39-45
Snyder, Rebekah; Liebman, Lauren S; Simon, Asher B et al. (2013) Does heterogeneity of depression diagnosis harm those with severe mood disorders? Med Hypotheses 81:316-8
Pier, Katherine S; Briggs, Mimi C; Pasculli, Rosa M et al. (2012) Successful electroconvulsive therapy for major depression misdiagnosed as Alzheimer dementia. Am J Geriatr Psychiatry 20:909-10
Popeo, Dennis M (2011) Delirium in older adults. Mt Sinai J Med 78:571-82
Smith, Glenn E; Rasmussen Jr, Keith G; Cullum, C Munro et al. (2010) A randomized controlled trial comparing the memory effects of continuation electroconvulsive therapy versus continuation pharmacotherapy: results from the Consortium for Research in ECT (CORE) study. J Clin Psychiatry 71:185-93
Rasmussen, Keith G; Mueller, Martina; Rummans, Teresa A et al. (2009) Is baseline medication resistance associated with potential for relapse after successful remission of a depressive episode with ECT? Data from the Consortium for Research on Electroconvulsive Therapy (CORE). J Clin Psychiatry 70:232-7
Husain, Mustafa M; McClintock, Shawn M; Rush, A John et al. (2008) The efficacy of acute electroconvulsive therapy in atypical depression. J Clin Psychiatry 69:406-11