Phase 4
N=138
Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT01907217 ↗Enrolled (actual)
138
Serious AEs
11.6%
Results posted
Nov 2018
Primary outcome: Primary: Hamilton Depression Rating Scale (HDRS) — 29.5; 30.4; 12.5; 11.1 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ECT Mecta 5000M (Device); Methohexitone (Drug); Suxamethonium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St Patrick's Hospital, Ireland
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale (HDRS) |
29.5; 30.4; 12.5; 11.1; 15.0; 11.5 | <0.05 sig |
| SECONDARY Columbia Autobiographical Memory Interview-Short Form (AMI-SF) |
52.9; 63.4 | 0.001 sig |
| SECONDARY Columbia Autobiographical Memory Interview-Short Form (AMI-SF) |
52.9; 63.4 | 0.001 sig |
| SECONDARY Columbia Autobiographical Memory Interview-Short Form (AMI-SF) |
52.9; 63.4 | 0.001 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01907217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.