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Completed

NCT Number: NCT00870805

Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St George Hospital, Kogarah, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral ultrabrief ECT

Procedure

Bilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms)

bilateral standard ECT

Procedure

Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)

right-unilateral ultrabrief ECT

Procedure

Right-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms)

right-unilateral standard ECT

Procedure

Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in scores on Depression Rating Scale

    Time frame: Before ECT, after each week of treatment, at the end of the ECT course

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Collaborators

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

Registry information

Official study title

A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)

Acronym: UB ECT

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 27, 2009
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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