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/study/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
Trial website
Trial related presentations / publications
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00870805