Depressive Disorder, Treatment-Resistant
Conditions
Keywords
Major depressive disorder (MDD), Bi-polar disorder (BP)
Brief summary
The purpose of this study is to examine the effects of sub-callosal cingulate (SCC) deep brain stimulation (DBS) in patients with treatment resistant depression (TRD). The working hypotheses are that long pulse-width DBS applied to the SCC region will lead to improvements in TRD patients, and specific neuroimaging biomarkers will correlate with response to DBS; the functional recovery will be enhanced with concurrent cognitive behavioural therapy (CBT).
Detailed description
The aim is to collect data on prediction, optimization and augmentation of DBS for TRD and develop tools for DBS surgery. It is a biological pilot study designed to provide informative data for future work.
Interventions
DEVICEdeep brain stimulation with short & long pulse width
surgical implantation for bilateral electrodes and stimulation using short and long pulse width
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* age 20-70 * diagnosis of major depressive (MDD)or bipolar disorder(BP)determined independently by 2 study psychiatrists * current major depressive episode of \>1 year duration, treatment-resistant (meaning failure to respond to 4 different classes of antidepressants, including augmentation or combination strategies with lithium, atypical antipsychotics, anticonvulsants, antidepressants, evidence-based psychotherapy, CBT, or electroconvulsive treatment despite adequate dosage, duration and compliance) * minimum score of 20 (out of 52) on the 17 item Hamilton Depression Rating Scale (HDRS) * resident of Alberta, Canada, covered by Alberta Health
Exclusion criteria
* other Axis I psychiatric disorders including schizophrenia, psychosis, active suicidal ideation over previous 6 months * cerebrovascular risk factors, previous stroke, head injury and neurodegenerative disorders, pregnancy, medical and general contraindications for DBS surgery (e.g. cardiac pacemaker/defibrillator) * age \>70 * diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale | 6 and 12 months post-operatively | change in HDRS from baseline before surgery: rates of remission (defined as an HDRS score \<8 at 6 and 12 months) and response (defined as \>50% reduction in HDRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on Illness Density Index, Montgomery-Asberg Depression Rating Scale and Hamilton Anxiety Scale, Positive and Negative Affect Scale, Clinical Global Impression of Change, GAF< SAs, NAS, Q-LES-Q-SF & neuropsychological tests | 6 and 12 months post operatively | change in MADRS score from baseline before surgery to 6 and 12 months post operatively |
| Post Cognitive Behavioural Therapy Scores | 15 months post operatively | Changes in primary and secondary measures from pre-CBT scores will be used |
Countries
Canada
Outcome results
None listed