DBS for Treatment Resistant Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Therapeutic Brain Stimulation for Refractory Depression

Conditions
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Depressive Disorder, Treatment-Resistant

Intervention / Treatment
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* Device: deep brain stimulation with short & long pulse width


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long Pulse Width<br>deep brain stimulation with short & long pulse width | Device: deep brain stimulation with short & long pulse width<br>* surgical implantation for bilateral electrodes and stimulation using short and long pulse width<br>|
| Experimental: Short Pulse Width<br>deep brain stimulation with short & long pulse width | Device: deep brain stimulation with short & long pulse width<br>* surgical implantation for bilateral electrodes and stimulation using short and long pulse width<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Depression Rating Scale | 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) | 6 and 12 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | change in MADRS score from baseline before surgery to 6 and 12 months post operatively | 6 and 12 months post operatively | 
| Post Cognitive Behavioural Therapy Scores | Changes in primary and secondary measures from pre-CBT scores will be used | 15 months post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depressive disorder (MDD), Bi-polar disorder (BP)