Phase 4
Completed N=138
Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression
Source: ClinicalTrials.gov NCT01907217 ↗Enrolled (actual)
138
Serious AEs
11.6%
Results posted
Nov 2018
Primary outcomePrimary: Hamilton Depression Rating Scale (HDRS) — 29.5; 30.4; 12.5; 11.1 units on a scale — p=<0.05
◆ Published Evidence
Established
21citations · ~4 / year
Usefulness of Hamilton rating scale for depression subset scales and full versions for electroconvulsive therapy.
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.
Linked Publications
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Usefulness of Hamilton rating scale for depression subset scales and full versions for electroconvulsive therapy.
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 |
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) and the linked publication. 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. Informational only — not medical advice.