Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)

Study Overview
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Brief Summary
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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.

Official Title
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A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Procedure: bilateral ultrabrief ECT
* Procedure: bilateral standard ECT
* Procedure: right-unilateral ultrabrief ECT
* Procedure: right-unilateral standard ECT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bilateral-ultrabrief ECT<br>Patients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold. | Procedure: bilateral ultrabrief ECT<br>* Bilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms)<br>|
| Active Comparator: bilateral standard ECT<br>Patients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold. | Procedure: bilateral standard ECT<br>* Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)<br>|
| Experimental: right-unilateral ultrabrief ECT<br>Patients will be treated with an ultrabrief (0.3ms) pulse with a right unilateral placement at 8 times seizure threshold. | Procedure: right-unilateral ultrabrief ECT<br>* Right-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms)<br>|
| Active Comparator: right-unilateral standard ECT<br>Patients will be treated with a standard (1.0ms) pulse with a right unilateral placement at 5 times seizure threshold. | Procedure: right-unilateral standard ECT<br>* Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on Depression Rating Scale |  | Before ECT, after each week of treatment, at the end of the ECT course |