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 #
3U01MH086127-05S1
Application #
8536004
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
2013-03-31
Budget Start
2012-09-12
Budget End
2013-03-31
Support Year
5
Fiscal Year
2012
Total Cost
$29,573
Indirect Cost
$9,858
Name
Georgia Regents University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
966668691
City
Augusta
State
GA
Country
United States
Zip Code
30912
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
McDonald, William M; Weiner, Richard D; Fochtmann, Laura J et al. (2016) The FDA and ECT. J ECT 32:75-7
Youssef, N A; McCall, W V (2016) Is Conduct of Research in Electroconvulsive Therapy Ethical? J Psychol Neuropsychiatr Disord Brain Stimul 1:
Youssef, Nagy A; McCall, W Vaughn (2015) Continuation antidepressant strategies after electroconvulsive therapy: ultrabrief pulse versus cognitive-behavioral therapy. Biol Psychiatry 77:e7
McCall, W Vaughn; Andrade, Chittaranjan; Sienaert, Pascal (2014) Searching for the mechanism(s) of ECT's therapeutic effect. J ECT 30:87-9
Youssef, Nagy A; McCall, W Vaughn (2014) Relapse prevention after index electroconvulsive therapy in treatment-resistant depression. Ann Clin Psychiatry 26:288-96
McCall, W Vaughn; Reboussin, David; Prudic, Joan et al. (2013) Poor health-related quality of life prior to ECT in depressed patients normalizes with sustained remission after ECT. J Affect Disord 147:107-11
McCall, W Vaughn; Kintziger, Kristina W (2013) Late life depression: a global problem with few resources. Psychiatr Clin North Am 36:475-81
Felkel 2nd, W Carson; Wagner, Gerhardt; Kimball, James et al. (2012) Tardive seizure with postictal aphasia: a case report. J ECT 28:180-2

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