Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00870805




Registration number
NCT00870805
Ethics application status
Date submitted
26/03/2009
Date registered
27/03/2009
Date last updated
27/02/2013

Titles & IDs
Public title
Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)
Scientific title
A Controlled Study of Ultrabrief Pulsewidth ECT (Electroconvulsive Therapy)
Secondary ID [1] 0 0
UNSW HREC 08322
Universal Trial Number (UTN)
Trial acronym
UB ECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - bilateral ultrabrief ECT
Treatment: Surgery - bilateral standard ECT
Treatment: Surgery - right-unilateral ultrabrief ECT
Treatment: Surgery - right-unilateral standard ECT

Experimental: bilateral-ultrabrief ECT - Patients will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 3-4 times seizure threshold.

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.

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.

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.


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

Treatment: Surgery: bilateral standard ECT
Bilateral ECT with at 1.5 times seizure threshold with a standard pulse (1.0ms)

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

Treatment: Surgery: right-unilateral standard ECT
Right-unilateral ECT with at 5 times seizure threshold with a standard pulse (1.0ms)
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in scores on Memory Tests
Timepoint [1] 0 0
Before ECT, after 6 ECT treatments, after final ECT treatment, one month and six month follow-up
Secondary outcome [1] 0 0
Change in scores on Depression Rating Scale
Timepoint [1] 0 0
Before ECT, after each week of treatment, at the end of the ECT course

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Wandene Private Hospital - Kogarah
Recruitment hospital [3] 0 0
The Melbourne Clinic - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Northside Clinic, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Melbourne Clinic, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
St George Hospital, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Wandene Private Hospital, Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00870805
Trial related presentations / 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.
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. Erratum In: Brain Stimul. 2008 Jul;1(3):A2.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Assoc/Prof Colleen K Loo, MBBS, FRANZCP, MD
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00870805