None listed
Conditions
Brief summary
Major depressive disorder is a common psychiatric illness that in a small subset of patients fails to respond to multiple trials of standard treatments including medication, psychotherapy and electroconvulsive therapy. In recent years, deep brain stimulation (DBS) has begun to be investigated as a novel intervention for patients with this kind of severe treatment resistant depression. In the proposed study, we will investigate the therapeutic efficacy of DBS applied to the bed nucleus of the stria terminalis. This brain region is an important junction point in depression relevant brain circuitry. We have obtained highly promising results in our pilot study of DBS applied to this brain region. In the proposed study, 16 patients will undergo the DBS operative procedure. Stimulation will be commenced in a randomised, controlled manner, including periods of active and sham stimulation and antidepressant responses will be evaluated in a blinded manner.
Interventions
Deep Brain Stimulation is a procedure that involves the surgical implantation of a small panel of closely spaced stimulation electrodes in specific highly localised brain regions. A stimulator (i.e. battery) is also implanted in the chest immediately below the clavicle, and a subcutaneous lead used to connect the electrodes to the stimulator.
Once the device has been implanted and switched on stimulation is delivered consistently to the brain. The stimulation settings are variable and can be a
Deep Brain Stimulation is a procedure that involves the surgical implantation of a small panel of closely spaced stimulation electrodes in specific highly localised brain regions. A stimulator (i.e. battery) is also implanted in the chest immediately below the clavicle, and a subcutaneous lead used to connect the electrodes to the stimulator. Once the device has been implanted and switched on stimulation is delivered consistently to the brain. The stimulation settings are variable and can be adjusted via an external remote control which is operated by the treating physician. The ideal stimulation settings differ between patients, and there is no one "right" set of parameters that are appropriate for everyone. Throughout the 10-weeks following onset of DBS adjustments to stimulation settings will be made fortnightly. After this period the frequency of adjustments will be made on an individual basis, and will not follow a set schedule. Patients who take part in the study will be observed and and followed up for at least two years following DBS implantation.
Sponsors
Monash Alfred Psychiatry Research Centre
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients will be included if they: 1. Have a DSM-IV diagnosis of a major depressive episode as confirmed by interview using the Structured Clinical Interview for DSM IV and review by two independent psychiatrists, 2. Age 18-70 years, 3. Have treatment resistant depression at Stage V of the Thase and Rush classification. This requires failure to respond to adequate courses of at least several different classes of antidepressants and a course of bilateral ECT. We will require patients to have failed to respond to trials of medications from all classes, ECT and cognitive behavioural therapy. 4. Have been depressed for a minimum of three years and have a Montgomery-Asberg Depression Rating Scale score of > 25 (moderate – severe depression), 5. Demonstration of capacity to give informed consent: this will be thoroughly assessed and documented by two independent psychiatrists and a neuropsychologist and via signing of the consent form.
Exclusion criteria
Patients who: 1. Have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating, 2. Significant concurrent Axis I or II psychiatric morbidity, 3. No evidence of substantive premorbid functioning after the age of 20 and within the last 15 years, including capacity to engage in prolonged relationships and meaningful functional activities (work, study, home-care).
Outcome results
None listed