Clinical trial NCT00870805: Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)
Official title: A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Northside Clinic, Australia
name: The Melbourne Clinic, Australia
name: St George Hospital, Australia
name: Wandene Private Hospital, Australia
First posted: 2009-03-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in scores on Memory Tests
timeFrame: Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up
Secondary outcomes:
measure: Change in scores on Depression Rating Scale
timeFrame: Before ECT, after each week of treatment, at the end of the ECT course
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: Wandene Private Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: The Melbourne Clinic
state: Victoria
Study officials:
affiliation: University of New South Wales
name: Assoc/Prof Colleen K Loo, MBBS, FRANZCP, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Melbourne Clinic
name: Prof Isaac Schweitzer, MBBS, FRANZCP, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.