DBS for Treatment Resistant Depression

N/ACompletedNCT01983904

University of Calgary22 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

deep brain stimulation with short & long pulse widthDEVICE

surgical implantation for bilateral electrodes and stimulation using short and long pulse width

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Calgary & Alberta Health Services, Foothills Medical Centre

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

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)

Time frame: 6 and 12 months post-operatively

Secondary Outcomes

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

Time frame: 6 and 12 months post operatively

Post Cognitive Behavioural Therapy Scores

Changes in primary and secondary measures from pre-CBT scores will be used

Time frame: 15 months post operatively

Data from ClinicalTrials.gov

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