Study Results
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Basic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2009-01-31
2013-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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bilateral-ultrabrief ECT
Patients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold.
bilateral ultrabrief ECT
Bilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms)
bilateral standard ECT
Patients will be treated with a standard (1.0ms) pulse with a bilateral placement at 1.5 times seizure threshold.
bilateral standard ECT
Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)
right-unilateral ultrabrief ECT
Patients will be treated with an ultrabrief (0.3ms) pulse with a right unilateral placement at 8 times seizure threshold.
right-unilateral ultrabrief ECT
Right-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms)
right-unilateral standard ECT
Patients will be treated with a standard (1.0ms) pulse with a right unilateral placement at 5 times seizure threshold.
right-unilateral standard ECT
Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)
Interventions
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bilateral ultrabrief ECT
Bilateral ECT at 3-4 times seizure threshold with an ultrabrief pulse (0.3ms)
bilateral standard ECT
Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)
right-unilateral ultrabrief ECT
Right-unilateral ECT at 6 times seizure threshold with an ultrabrief pulse (0.3ms)
right-unilateral standard ECT
Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)
Eligibility Criteria
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Inclusion Criteria
* Total MADRS score \>/= 25
* Age \>/= 18 years
* Educated or working in an English medium setting
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Northside Clinic, Australia
OTHER
The Melbourne Clinic, Australia
UNKNOWN
St George Hospital, Australia
OTHER
Wandene Private Hospital, Australia
UNKNOWN
The University of New South Wales
OTHER
Responsible Party
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University of New South Wales
Principal Investigators
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Assoc/Prof Colleen K Loo, MBBS, FRANZCP, MD
Role: PRINCIPAL_INVESTIGATOR
University of New South Wales
Prof Isaac Schweitzer, MBBS, FRANZCP, MD
Role: PRINCIPAL_INVESTIGATOR
The Melbourne Clinic
Locations
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St George Hospital
Kogarah, New South Wales, Australia
Wandene Private Hospital
Kogarah, New South Wales, Australia
The Melbourne Clinic
Melbourne, Victoria, Australia
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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UNSW HREC 08322
Identifier Type: -
Identifier Source: org_study_id
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