NCT00870805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 major-depressive-disorder

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4 major-depressive-disorder

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 27, 2013

Status Verified

September 1, 2011

Enrollment Period

4 years

First QC Date

March 26, 2009

Last Update Submit

February 26, 2013

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in scores on Memory Tests

    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

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

Study Arms (4)

bilateral-ultrabrief ECT

EXPERIMENTAL

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 standard ECT

ACTIVE COMPARATOR

Patients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold.

Procedure: bilateral standard ECT

right-unilateral ultrabrief ECT

EXPERIMENTAL

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 standard ECT

ACTIVE COMPARATOR

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

bilateral ultrabrief ECTPROCEDURE

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

bilateral-ultrabrief ECT
bilateral standard ECTPROCEDURE

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

bilateral standard ECT
right-unilateral ultrabrief ECTPROCEDURE

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

right-unilateral ultrabrief ECT
right-unilateral standard ECTPROCEDURE

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

right-unilateral standard ECT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Wandene Private Hospital

Kogarah, New South Wales, 2217, Australia

Location

The Melbourne Clinic

Melbourne, Victoria, Australia

Location

Related Publications (7)

  • 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.

    PMID: 16866758BACKGROUND

  • 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.

    PMID: 17706790BACKGROUND

  • 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.

    PMID: 18752719BACKGROUND

  • 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.

    PMID: 19756236BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 31056081DERIVED

  • 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.

    PMID: 25522389DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Assoc/Prof Colleen K Loo, MBBS, FRANZCP, MD

    University of New South Wales

    PRINCIPAL INVESTIGATOR

  • Prof Isaac Schweitzer, MBBS, FRANZCP, MD

    The Melbourne Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 27, 2013

Record last verified: 2011-09

Locations

AU(3)