Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression
Information source: St Patrick's Hospital, Ireland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: ECT Mecta 5000M (Device); Methohexitone (Drug); Suxamethonium (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: St Patrick's Hospital, Ireland Official(s) and/or principal investigator(s): Declan M McLoughlin, PhD, Principal Investigator, Affiliation: St Patrick's University Hospital
Summary
Electroconvulsive therapy (ECT) is the most powerful antidepressant treatment available and
is often life-saving. There are concerns, however, that standard bitemporal ECT (the most
commonly used form of ECT worldwide) causes persisting retrograde amnesia. However, clinical
trials have indicated that high-dose unilateral ECT may be as effective as bitemporal ECT
but have much less cognitive side-effects.
The trial aims to test the primary experimental hypothesis: High-dose (6 x ST) right
unilateral ECT is as effective as (i. e. not inferior to) standard (1. 5 x ST) bitemporal ECT
for severe depression in terms of Hamilton Depression Rating Score (HDRS) at the end of the
treatment course.
Clinical Details
Official title: A Randomised Controlled Trial of Standard Bilateral Electroconvulsive Therapy Versus High-dose Unilateral Electroconvulsive Therapy for Severe Depression
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline in Hamilton Depression Rating Scale (HDRS)
Secondary outcome: Change from baseline in Hamilton Depression Rating Scale (HDRS)Change from baseline in Hamilton Depression Rating Scale (HDRS) Change from baseline in Hamilton Depression Rating Scale (HDRS) Change from baseline in Hamilton Depression Rating Scale (HDRS) Columbia Autobiographical Memory Interview-Short Form (AMI-SF)
Detailed description:
The study is a two-group parallel design randomised controlled non-inferiority trial and has
been registered (ISRCTN23577151). Consented patients with major depressive disorder (DSM-IV)
will be randomly allocated to a course of bitemporal (BT) ECT (1. 5 x ST) or high-dose right
unilateral (RUL) ECT (6. 0 x ST). To facilitate generalizability of results, the trial takes
place under "real world" conditions and so both groups continue usual care and medications
during the treatment phase and thereafter. Patients are followed-up for 12 months after
completing their allocated course of ECT. Completion of the primary outcome
depression-rating measure (i. e. HDRS) and the secondary outcome of most interest
(autobiographical memory, using the AMI-SF) will be prioritised in the data collection.
Patients, their treating clinicians and raters are blind to treatment; clinicians
administering ECT are not involved in post randomisation assessments or formal data
analysis. Success of blinding for patients and raters will be assessed after the second and
final treatments. The trial statistician is also blinded to allocation status.
Sample size: In a large series (n = 253) of depressed patients, Petrides et al. (2001) found
a mean (SD) reduction in 24-item HDRS of 25. 6 (9. 4) after treatment with bitemporalT ECT
(1. 5 x ST). We therefore estimate that 69 patients will be required per treatment group to
have 80% power to demonstrate, using a one-sided equivalence t-test at 5% level, that mean
reduction in 24-item HDRS achieved using high-dose RUL ECT is no more than 4 points (i. e.
equivalent to 3 points on 17-item HDRS) less than that achieved using standard BT ECT,
assuming a common within-group SD of change scores of 9. 4 and equal expected group mean
change scores.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients ≥18 years diagnosed with major depressive episode (DSM-IV) and referred for
ECT
Exclusion Criteria:
- Any condition rendering patients medically unfit for general anaesthesia or ECT;
treatment with ECT in previous six months; dementia or other Axis 1 diagnosis;
alcohol/other substance abuse in previous six months; inability/refusal to consent.
Locations and Contacts
St Patrick's University Hospital, Dublin 8, Ireland
Additional Information
Click here for more information about the research group.
Starting date: May 2008
Last updated: December 31, 2014
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