Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT) (UB ECT)

February 26, 2013 updated by: The University of New South Wales

A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital
      • Kogarah, New South Wales, Australia, 2217
        • Wandene Private Hospital
    • Victoria
      • Melbourne, Victoria, Australia
        • The Melbourne Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in scores on Memory Tests
Time Frame: Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up
Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Collaborators

St George Hospital, Australia
Northside Clinic, Australia
The Melbourne Clinic, Australia
Wandene Private Hospital, Australia

Investigators

  • Principal Investigator: Assoc/Prof Colleen K Loo, MBBS, FRANZCP, MD, University of New South Wales
  • Principal Investigator: Prof Isaac Schweitzer, MBBS, FRANZCP, MD, The Melbourne Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNSW HREC 08322

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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