Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT) (UB ECT)

This study has been completed.
Sponsor:
Collaborators:
Northside Clinic, Australia
The Melbourne Clinic, Australia
St George Hospital, Australia
Wandene Private Hospital, Australia
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00870805
First received: March 26, 2009
Last updated: February 26, 2013
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Procedure: bilateral ultrabrief ECT
Procedure: bilateral standard ECT
Procedure: right-unilateral ultrabrief ECT
Procedure: right-unilateral standard ECT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)

Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in scores on Depression Rating Scale [ Time Frame: Before ECT, after each week of treatment, at the end of the ECT course ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: January 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870805

Locations
Australia, New South Wales
St George Hospital
Kogarah, New South Wales, Australia, 2217
Wandene Private Hospital
Kogarah, New South Wales, Australia, 2217
Australia, Victoria
The Melbourne Clinic
Melbourne, Victoria, Australia
Sponsors and Collaborators
The University of New South Wales
Northside Clinic, Australia
The Melbourne Clinic, Australia
St George Hospital, 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
  More Information

Publications:
Sackeim, H.A., Prudic, J., Nobler, M.S., Fitzsimons, L., Lisanby, S.H., Payne, N. et al. (2008). Effects of pulsewidth and electrode placement on the efficacy and cognitive side effects of electroconvulsive therapy. Brain Stimulation, 1, 71-83.
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.

Responsible Party: Associate Professor Colleen Loo, University of New South Wales
ClinicalTrials.gov Identifier: NCT00870805     History of Changes
Other Study ID Numbers: UNSW HREC 08322
Study First Received: March 26, 2009
Last Updated: February 26, 2013
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 19, 2014