None listed
Conditions
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.
Interventions
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
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.
Sponsors
Monash Alfred Psychiatry Research Centre
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed