Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Procedure: bilateral ultrabrief ECT; Procedure: right-unilateral ultrabrief ECT; Procedure: bilateral standard ECT; Procedure: right-unilateral standard ECT

• Registration Number: NCT00870805
• Lead Sponsor: The University of New South Wales

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Status Verified: 2011-09
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bilateral-ultrabrief ECT	bilateral ultrabrief ECT	Patients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold.
right-unilateral ultrabrief ECT	right-unilateral ultrabrief ECT	Patients will be treated with an ultrabrief (0.3ms) pulse with a right unilateral placement at 8 times seizure threshold.
bilateral standard ECT	bilateral standard ECT	Patients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold.
right-unilateral standard ECT	right-unilateral standard ECT	Patients will be treated with a standard (1.0ms) pulse with a right unilateral placement at 5 times seizure threshold.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in scores on Depression Rating Scale	Before ECT, after each week of treatment, at the end of the ECT course

Trial Locations

Locations (3)

The Melbourne Clinic; 🇦🇺 Melbourne, Victoria, Australia

St George Hospital; 🇦🇺 Kogarah, New South Wales, Australia

Wandene Private Hospital; 🇦🇺 Kogarah, New South Wales, Australia