Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000889954
Ethics application status
Approved
Date submitted
1/08/2011
Date registered
19/08/2011
Date last updated
3/12/2020
Date data sharing statement initially provided
3/12/2020
Date results information initially provided
3/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Study of Deep Brain Stimulation for Treatment Resistant Major Depression
Scientific title
A pilot study to evaluate the effect of deep brain stimultion on the severity of depressive symptoms in patients with severe treatment resistant depression.
Secondary ID [1] 262737 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment resistant major depression 270445 0
Condition category
Condition code
Mental Health 270592 270592 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Deep Brain Stimulation (DBS) using Medtronics Kinetra Model 7428.

DBS is a neurosurgical procedure that involves the precise implantation of very small electrodes into targeted regions of the brain. These electrodes are powered by a stimulating battery which is implanted under the skin in the chest. The type of stimulation that is delivered can be adjusted using an external remote control which is operated by the treating doctor.

The stimulation parameters include the combination of electrodes activated, electrode reference scheme, voltage, frequency and pulse width. In the current study all stimulation parameters will be individualised for each patient. They will be titrated over a period of weeks or months (depending on individual patient response) and once the optimal settings for each patient are identified stimulation will remain ongoing indefinitely.
Intervention code [1] 267083 0
Treatment: Devices
Intervention code [2] 269227 0
Treatment: Surgery
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269334 0
Primary Outcome 1: change in severity of depressive symptoms, defined as:

Montgomery Asberg Depression Rating Scale
50% reduction = clinical response
<8 = clinical remission
Timepoint [1] 269334 0
Timepoint: baseline, post implantation / pre-stimulation onset, six months post stimulation onset, one year post stimulation onset.
Secondary outcome [1] 279399 0
Secondary Outcome 1: cognition as measured via standardised neuropsychology tasks.

- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; Versions A & B)

- Controlled Oral Word Association Test (FAS/CFL)

- Trail Making Test (A & B)

- Golden Stroop Test

- Letter Number Sequencing subtest (WAIS?III)
Timepoint [1] 279399 0
Timepoint: baseline, one year post stimulation onset
Secondary outcome [2] 279400 0
Secondary Outcome 2: Quality of life as measured via the Quality of Life Enjoyment and Satisfaction Scale: Short Form
Timepoint [2] 279400 0
Timepoint: baseline, post implantation / pre-stimulation onset, six months post stimulation onset, one year post stimulation onset.
Secondary outcome [3] 279401 0
Secondary Outcome 3: Social functioning as measured via the Social Adaptation Self-Evaluation Scale
Timepoint [3] 279401 0
Timepoint: baseline, post implantation / pre-stimulation onset, six months post stimulation onset, one year post stimulation onset.

Eligibility
Key inclusion criteria
1. Have a DSM-IV diagnosis of a major depressive episode as confirmed by both SCID interview and independent psychiatrist review (X2)

2. Age 18-70

3. Have treatment resistant depression at Stage V of the Thase and Rush classification. This is a very strict definition of TRD and requires failure to respond to adequate courses of at least several different classes of antidepressants and a course of bilateral ECT.

4. Have a Montgomery-Asberg Depression Rating Scale score of > 25 (moderate – severe depression)

5. Demonstration of capacity to give informed consent: this will need to be assessed and documented by two independent psychiatrists and signing of the consent form will take place in the presence of an independent consent monitor. Consent capacity will also be reviewed by the Victorian Psychosurgery Review Board.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating

2. Immediate suicide risk

3. Significant concurrent axis 1 or 11 psychiatric morbidity.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/07/2007
Actual
2/07/2007
Date of last participant enrolment
Anticipated
Actual
1/06/2012
Date of last data collection
Anticipated
Actual
3/06/2013
Sample size
Target
10
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 267555 0
Hospital
Name [1] 267555 0
Monash Alfred Psychiatry Research Centre
Country [1] 267555 0
Australia
Funding source category [2] 267556 0
Commercial sector/Industry
Name [2] 267556 0
Medtronic Inc
Country [2] 267556 0
United States of America
Primary sponsor type
Hospital
Name
Monash Alfred Psychiatry Research Centre
Address
Alfred Hospital
First Floor Old Baker Building
Commercial Rd
Prahran VIC
3181
Country
Australia
Secondary sponsor category [1] 266611 0
None
Name [1] 266611 0
Address [1] 266611 0
Country [1] 266611 0
Other collaborator category [1] 252160 0
Individual
Name [1] 252160 0
Assoc Prof Richard Bittar
Address [1] 252160 0
Royal Melbourne Hospital
Grattan St
Parkville VIC
3050
Country [1] 252160 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269517 0
Alfred Human Research and Ethics Committee
Ethics committee address [1] 269517 0
Alfred Hospital
Ground Floor, Linay Pavilion
Commercial Rd
Prahran VIC
3181
Ethics committee country [1] 269517 0
Australia
Date submitted for ethics approval [1] 269517 0
Approval date [1] 269517 0
22/06/2005
Ethics approval number [1] 269517 0
1/04/0151

Summary
Brief summary
The project is a pilot study of the therapeutic efficacy of Deep Brain Stimulation (DBS) in patients with severe depression that has not responded to treatment with all other standard antidepressant treatments. DBS involves the placement of small stimulating electrodes into the brain which are connected to a pacemaker like device which is implanted under the skin. The electrodes are used to stimulate a small brain area called the nucleus accumbens. DBS is now widely used in Australia and overseas for the treatment of neurological conditions, such as Parkinson’s disease and essential tremor. When performed by an experienced team it appears to be gnerally safe and well tolerated.
A small body of work looking at the impact of DBS in obsessive compulsive disorder has indicated that DBS can affect mood and may be an effective treatment for major depression. There are a small percentage of patients with major who do not respond to any of the standard antidepressant treatment options. these patients are debilitated by their illness and remain at very high risk of death by suicide. We aim to trial DBS in a small number of carefully selected patients in an open trial. We will evaluate the efficacy of the treatment by video recording interviews with patients describing their depression and having the severity of depression rated by a trained rater who is unaware of whether the interview was conducted before or after the procedure.
All patients will be carefully selected and assessed to ensure they can provide informed consent. The participation of each patient will be independently reviewed by the Victorian Government Psychosurgery Review Board, an independent statutory authority.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32952 0
Prof Paul Fitzgerald
Address 32952 0
888 Toorak Rd Camberwell, Vic,
Country 32952 0
Australia
Phone 32952 0
+61 3 9805 4287
Fax 32952 0
Email 32952 0
paul.fitzgerald@monash.edu
Contact person for public queries
Name 16199 0
Prof Paul Fitzgerald
Address 16199 0
888 Toorak Rd Camberwell, Vic,
Country 16199 0
Australia
Phone 16199 0
+61 3 9805 4287
Fax 16199 0
Email 16199 0
paul.fitzgerald@monash.edu
Contact person for scientific queries
Name 7127 0
Prof Paul Fitzgerald
Address 7127 0
888 Toorak Rd Camberwell, Vic,
Country 7127 0
Australia
Phone 7127 0
+61 3 9805 4287
Fax 7127 0
Email 7127 0
paul.fitzgerald@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 407. P. B. Fitzgerald, R. Segrave, K. E. Richardso... [More Details] 343274-(Uploaded-09-07-2020-15-33-30)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA pilot study of bed nucleus of the stria terminalis deep brain stimulation in treatment-resistant depression.2018https://dx.doi.org/10.1016/j.brs.2018.04.013
N.B. These documents automatically identified may not have been verified by the study sponsor.