Clinical Trial Details

A Pilot Study of Deep Brain Stimulation for Treatment Resistant Major Depression

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Trial Information

Broad Health Condition Mental Health

Specific Health ConditionDepression

Trial FocusTreatment

Recruitment statusCompleted

Recruitment Details
Recruitment State
VIC

Anticipated date of first participant enrolment2/07/2007

Anticipated date of last participant enrolment2/07/2007

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Trial 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.
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 age18 Years

Maximum age70 Years

GenderBoth 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.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Monash Alfred Psychiatry Research Centre
Primary Sponsor Address: Alfred Hospital First Floor Old Baker Building Commercial Rd Prahran VIC 3181
Primary Sponsor Country: Australia

Trial IDACTRN12611000889954

Contact person for information and recruitmentProf
Paul Fitzgerald
888 Toorak Rd Camberwell, Vic,
+61 3 9805 4287

Further information iconpaul.fitzgerald@monash.edu
Australia