Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000177055
Ethics application status
Approved
Date submitted
26/01/2010
Date registered
26/02/2010
Date last updated
26/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of efficacy and cognitive side effects of bifrontal and bitemporal electroconvulsive therapy (ECT) for major depression
Scientific title
Comparison of efficacy and cognitive side effects of bifrontal and bitemporal electroconvulsive therapy (ECT) for major depression
Secondary ID [1] 1333 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Electrode placement in electroconvulsive therapy 256676 0
Major depression 256879 0
Condition category
Condition code
Mental Health 256833 256833 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bifrontal electrode placement, with each electrode placed 5 cm above the outer angle of the orbit on a line parallel to the sagittal plane. Treatment was given with a square-wave, brief-pulse, constant-current device for stimulating a seizure lasting a minimum of 20 seconds going up to a maximum of 60 seconds. It was administred three times a week, until remission or completing twelve treatments.
Intervention code [1] 255907 0
Treatment: Devices
Comparator / control treatment
Bitemporal electrode placement, with each electrode placed on the perpendicular line 3 cm above the midpoint of the line joining the external auditory meatus and the outer canthus of the eye. Treatment was given with a square-wave, brief-pulse, constant-current device for stimulating a seizure lasting a minimum of 20 seconds going up to a maximum of 60 seconds. It was administred three times a week, until remission or completing twelve treatments.
Control group
Active

Outcomes
Primary outcome [1] 257697 0
Severity of depression, as measured by the Montgomery and Asberg Depression Rating Scale (MADRS)
Timepoint [1] 257697 0
At baseline and at 9,18 and 27 days after intervention commenced
Primary outcome [2] 257698 0
Cognitive deficits, as measure by the Rey Auditory Verbal Learning Test (RAVLT)
Timepoint [2] 257698 0
At baseline and at 9,18 and 27 days after intervention commenced
Secondary outcome [1] 263043 0
Severity of depression, as measured by the Clinical Global Impression(CGI) score
Timepoint [1] 263043 0
At baseline and at 9,18 and 27 days after intervention commenced
Secondary outcome [2] 263044 0
Cognitive deficits, as measured by the Mini-Mental State Examination (MMSE)
Timepoint [2] 263044 0
At baseline and at 9,18 and 27 days after intervention commenced

Eligibility
Key inclusion criteria
Major depressive episode in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, with scores > or = 21 in MADRS and > or = 4 in CGI
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior diagnosis of schizophrenia, schizoaffective disorder, rapid-cycling bipolar disorder, substance dependence, dementia, neuropsychiatric disorders or severe non-psychiatric diseases; ECT treatment in the previous six months

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?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment outside Australia
Country [1] 2439 0
Brazil
State/province [1] 2439 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 256404 0
Self funded/Unfunded
Name [1] 256404 0
Country [1] 256404 0
Primary sponsor type
Hospital
Name
IPSEMG/ Hospital Governador Israel Pinheiro
Address
Alameda Ezequiel Dias, 225, 11o. andar,
Santa Efigenia.
Belo Horizonte - MG
ZIP code 30130-110
Country
Brazil
Secondary sponsor category [1] 251711 0
Individual
Name [1] 251711 0
Paulo Jose Ribeiro Teixeira
Address [1] 251711 0
Rua Fernandes Tourinho, 470, sl. 903.
Belo Horizonte- MG
ZIP code 30112-000
Country [1] 251711 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258461 0
Comite de Etica em Pesquisa- CEP/HGIP
Ethics committee address [1] 258461 0
Alameda Ezequiel Dias, 225, 11o. andar,
Santa Efigenia.
Belo Horizonte - MG
ZIP code 30130-110
Ethics committee country [1] 258461 0
Brazil
Date submitted for ethics approval [1] 258461 0
25/04/2000
Approval date [1] 258461 0
15/05/2000
Ethics approval number [1] 258461 0
026/00

Summary
Brief summary
Comparison of efficacy and cognitive side effects of bifrontal and bitemporal ECT for major depression
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30766 0
Address 30766 0
Country 30766 0
Phone 30766 0
Fax 30766 0
Email 30766 0
Contact person for public queries
Name 14013 0
Paulo Jose Ribeiro Teixeira
Address 14013 0
Rua Fernandes Tourinho, 470, sl. 903.
Belo Horizonte - MG
ZIP Code 30112-000
Country 14013 0
Brazil
Phone 14013 0
+55 31 3227-0030
Fax 14013 0
Email 14013 0
[email protected]
Contact person for scientific queries
Name 4941 0
Paulo Jose Ribeiro Teixeira
Address 4941 0
Rua Fernandes Tourinho, 470, sl. 903.
Belo Horizonte - MG
ZIP Code 30112-000
Country 4941 0
Brazil
Phone 4941 0
+55 31 3227-0030
Fax 4941 0
Email 4941 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.