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Prolonging Remission in Depressed Elderly (PRIDE)

Mount Sinai Health System logo

Mount Sinai Health System

Status and phase

Completed
Phase 4

Conditions

Depression

Treatments

Procedure: ECT
Drug: lithium and Venlafaxine

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01028508
U01MH055495 (U.S. NIH Grant/Contract)
GCO 09-0429

Details and patient eligibility

About

This study will determine whether medications alone or medications and electroconvulsive therapy (ECT) work best to prevent depressive relapse and to improve quality of life for older people with severe mood disorders.

Full description

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.

Enrollment

247 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

247 participants in 2 patient groups

PHARM
Active Comparator group
Description:
lithium and venlafaxine
Treatment:
Drug: lithium and Venlafaxine
STABLE
Experimental group
Description:
ECT + VLF + Li
Treatment:
Procedure: ECT

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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