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CompletedNCT00870805UB ECTUpdated Feb 27, 2013

Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)

A Phase 4 interventional study of bilateral ultrabrief ECT and bilateral standard ECT in Major Depressive Disorder, sponsored by The University of New South Wales. Completed at 3 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-27.

Sponsored by The University of New South Wales · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Major Depressive Disorder
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In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 150 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

The University of New South Wales is the lead sponsor of 65 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

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)

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What researchers measure

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

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Study locations

3 sites
  • St George Hospital
    Kogarah, New South Wales 2217, Australia
  • Wandene Private Hospital
    Kogarah, New South Wales 2217, Australia
  • The Melbourne Clinic
    Melbourne, Victoria, Australia
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References and documents

Publications

  • Loo CK, Schweitzer I, Pratt C. Recent advances in optimizing electroconvulsive therapy. Aust N Z J Psychiatry. 2006 Aug;40(8):632-8. doi: 10.1080/j.1440-1614.2006.01862.x. PubMed 16866758 ↗
  • Loo C, Sheehan P, Pigot M, Lyndon W. A report on mood and cognitive outcomes with right unilateral ultrabrief pulsewidth (0.3 ms) ECT and retrospective comparison with standard pulsewidth right unilateral ECT. J Affect Disord. 2007 Nov;103(1-3):277-81. doi: 10.1016/j.jad.2007.06.012. Epub 2007 Aug 16. PubMed 17706790 ↗
  • Loo CK, Sainsbury K, Sheehan P, Lyndon B. A comparison of RUL ultrabrief pulse (0.3 ms) ECT and standard RUL ECT. Int J Neuropsychopharmacol. 2008 Nov;11(7):883-90. doi: 10.1017/S1461145708009292. Epub 2008 Aug 28. PubMed 18752719 ↗
  • Sackeim HA, Prudic J, Nobler MS, Fitzsimons L, Lisanby SH, Payne N, Berman RM, Brakemeier EL, Perera T, Devanand DP. Effects of pulse width and electrode placement on the efficacy and cognitive effects of electroconvulsive therapy. Brain Stimul. 2008 Apr;1(2):71-83. doi: 10.1016/j.brs.2008.03.001. Erratum In: Brain Stimul. 2008 Jul;1(3):A2. PubMed 19756236 ↗
  • Sienaert, P., Vansteelandt, K., Demyttenaere, K., & Peuskens, J. (2006). Comparison of bifrontal and unilateral ultra-brief pulse electroconvulsive therapy for depression. European Neuropsychopharmacology, 16 (suppl 4), S28.
  • Martin D, Katalinic N, Hadzi-Pavlovic D, Ingram A, Ingram N, Simpson B, McGoldrick J, Dowling N, Loo C. Cognitive effects of brief and ultrabrief pulse bitemporal electroconvulsive therapy: a randomised controlled proof-of-concept trial. Psychol Med. 2020 May;50(7):1121-1128. doi: 10.1017/S0033291719000989. Epub 2019 May 2. PubMed 31056081 ↗
  • Loo CK, Katalinic N, Smith DJ, Ingram A, Dowling N, Martin D, Addison K, Hadzi-Pavlovic D, Simpson B, Schweitzer I. A randomized controlled trial of brief and ultrabrief pulse right unilateral electroconvulsive therapy. Int J Neuropsychopharmacol. 2014 Dec 5;18(1):pyu045. doi: 10.1093/ijnp/pyu045. Erratum In: Int J Neuropsychopharmacol. 2016 Apr 27;19(10):pyw031. doi: 10.1093/ijnp/pyw031. PubMed 25522389 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00870805
Lead sponsor
The University of New South Wales
Collaborators
Northside Clinic, Australia, The Melbourne Clinic, Australia, St George Hospital, Australia, Wandene Private Hospital, Australia
First posted
Mar 27, 2009
Start date
Jan 2009
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Feb 27, 2013

Study contacts

Assoc/Prof Colleen K Loo, MBBS, FRANZCP, MD
principal investigator · University of New South Wales
Prof Isaac Schweitzer, MBBS, FRANZCP, MD
principal investigator · The Melbourne Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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