Major Depressive Disorder
Conditions
Brief summary
Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is one of the safest and most effective treatments available for depression. Despite modern advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive treatment with ECT. Its use, however, is limited by concerns over associated cognitive side effects. Recent research has suggested that using an ultrabrief pulsewidth with ECT may greatly reduce cognitive side effects, while maintaining efficacy (Sackeim et al 2008). Preliminary results were positive for unilateral ECT, however, suggest that for bilateral ECT, dosing may need to be adjusted to preserve efficacy while reducing side effects. This study will examine the relative cognitive side effects and efficacy of right unilateral and bilateral ECT given with a standard pulsewidth or an ultrabrief pulsewidth. Some participants will also receive an MRI scan before and after ECT.
Interventions
PROCEDUREbilateral ultrabrief ECT
Bilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms)
PROCEDUREbilateral standard ECT
Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)
PROCEDUREright-unilateral ultrabrief ECT
Right-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms)
PROCEDUREright-unilateral standard ECT
Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)
Sponsors
Northside Clinic, Australia
The Melbourne Clinic, Australia
St George Hospital, Australia
Wandene Private Hospital, Australia
The University of New South Wales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects meet criteria for a DSM-IV-TR Major Depressive Episode * Total MADRS score \>/= 25 * Age \>/= 18 years * Educated or working in an English medium setting
Exclusion criteria
* Diagnosis (as defined by DSM-IV-TR) of any psychotic disorder (lifetime with exception of Major Depressive Episode with psychotic features); rapid cycling bipolar disorder, eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year). * history of drug or alcohol abuse or dependence (as per DSM-IV-TR) in the last 6 months (except nicotine and caffeine). * ECT in last 3 months * Subject requires an urgent clinical response due to inanition, psychosis or high suicide risk * unable to give informed consent * score \< 24 on Mini Mental State Examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in scores on Memory Tests | Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Change in scores on Depression Rating Scale | Before ECT, after each week of treatment, at the end of the ECT course |
Countries
Australia
Outcome results
None listed