Prolonging Remission in Depressed Elderly (PRIDE)

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 trial builds upon the work of the Consortium for Research in Electroconvulsive Therapy
(CORE) group that showed that continuation ECT and combination pharmacotherapy were equally
effective in preventing relapse following response to acute ECT. We are now testing whether
combined pharmacotherapy and ECT, individualized according to patient response, will be more
effective in maintaining remission in depressed older adults than pharmacotherapy alone.
Moving beyond the traditional fixed schedule for continuation ECT, we are introducing a
novel Symptom-Titrated Algorithm-Based Longitudinal ECT (STABLE) regimen. The STABLE
algorithm ensures that the timing of ECT treatments is based upon clinical need, helping to
achieve the dual goals of adequately treating people showing early signs of symptom
re-emergence, while preventing the over-treatment of patients who may be in a stable
remission. The continuation therapy "usual care" comparator arm is the combination
pharmacotherapy of Li plus VLF (PHARM).

At 7 sites, 322 patients will receive an acute course of right unilateral (RUL) ECT
augmented by standardized medication (Phase I); 188 remitters are randomly assigned to one
of the 2 groups and followed for 6 months (Phase II). To balance the amount of clinical
contact, the schedule of clinic and telephone ratings will be identical for patients in both
the PHARM and STABLE arms. For both groups, relapse is defined as Hamilton Rating Scale for
Depression-24 (HRSD24) scores >21 at two consecutive time points, suicidality, or
psychiatric hospitalization.

Inclusion Criteria:

- DSM-IV diagnosis of major depressive episode, unipolar, based on the
Mini-International Neuropsychiatric Interview (M.I.N.I) for DSM-IV

- ECT is clinically indicated

Exclusion Criteria:

- Lifetime history of bipolar affective disorder, schizophrenia, schizoaffective
disorder, or mental retardation

- Current diagnosis of delirium, dementia, or substance abuse/dependence in past 6
months as defined by DSM-IV-TR criteria