Prolonging Remission in Depressed Elderly (PRIDE)
Overview
- Phase
- Phase 4
- Intervention
- lithium and Venlafaxine
- Conditions
- Depression
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 247
- Locations
- 10
- Primary Endpoint
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
PHARM
lithium and venlafaxine
Intervention: lithium and Venlafaxine
STABLE
ECT + VLF + Li
Intervention: ECT
Outcomes
Primary Outcomes
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Time Frame: Measured at clinic visits at week 24
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23
Secondary Outcomes
- Level of functioning (SF-36)(Measured at week 24)
- Tolerability (Mini Mental State Examination [MMSE])(Measured at week 24)
- Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])(Measured at week 24)
- Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency(Measured at weeks 24)
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)(Measured at week 24)