Electroconvulsive therapy (ECT) continues to be an important treatment for preventing relapse of severe depression and sustaining mood improvements, especially in the geriatric community, according to research published in The American Journal of Psychiatry.
The PRIDE (Prolonging Remission in Depressed Elderly, ClinicalTrials.gov Identifier: NCT01028508) study, which began in 2009 under funding from the National Institute of Mental Health (NIMH), was a randomized, multicenter study that contrasted 2 post-ECT continuation treatment strategies. The first was a medication-only arm, which included aggressive standard-of-care pharmacotherapy combined with venlafaxine and lithium carbonate. The second arm added 4 continuation ECT treatments to medication, followed by an individualized, flexible, algorithm-based ECT schedule called Symptom-Titrated, Algorithm-Based Longitudinal ECT [STABLE].
The trial consisted of 2 phases. In the first phase, 1240 patients older than 60 years with unipolar major depressive disorder received acute ECT 3 times per week in combination with open-label venlafaxine. In phase 2, the intent-to-treat sample consisted of 120 patients who experienced remission in phase 1 and were randomly assigned to receive either venlafaxine or lithium alone or ECT plus medication. The primary efficacy outcome measure was scored using the 24-item Hamilton Depression Rating Scale (HAM-D), while the secondary efficacy outcome was scored using the Clinical Global Impressions severity scale (CGI-S).
Of the 240 patients who began phase 1, 148 (62%) experienced remission and were eligible for randomization. A total of 120 patients who consented for the second phase received at least one randomized treatment and were included in the intent-to-treat sample. Demographic and baseline clinical characteristics were similar for the groups, except for the presence of psychotic features at baseline. (The patterns for dropouts across demographic and clinical indicators were not significantly different for the 2 treatment arms.)
At 24 weeks, the combined ECT and medication arm had statistically significantly lower HAM-D scores than the medication-only arm. The difference in adjusted mean HAM-D scores at study end was 4.2 (95% Cl; 1.6-6.9). Significantly more patients in the ECT plus medication group were rated “not ill at all” on the CGI-S compared with the medication-only group.
These data demonstrate that additional ECT after remission was beneficial in sustaining mood improvement for most patients in a vulnerable geriatric population.
Limitations of the study include potential non-generalizability of the findings due to the acknowledged bias of a sample willing to consent to a complex research study, and sample size constraints for feasibility that necessitated the use of depression symptom severity rather than relapse as the primary outcome variable.
Findings from PRIDE indicate that continuing ECT after remission, rather than abruptly ending a course of ECT, is likely to be beneficial in sustaining mood improvement for most patients. Additionally, clinicians should be willing to prescribe additional ECT if patients begin to show symptom reemergence. Tapering a course of ECT and early intervention with additional ECT if symptoms worsen can prevent full syndromic relapse and its potentially catastrophic consequences.
Kellner CH, Husain MM, Knapp RG, et al. A novel strategy for continuation ECT in geriatric depression: phase 2 of the PRIDE study. Am J Psychiatry. 2016; doi:10.1176/appiajp.2016.16010118.