Clinical trial NCT01983904: DBS for Treatment Resistant Depression
Official title: Therapeutic Brain Stimulation for Refractory Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Treatment-Resistant
Keywords: Major depressive disorder (MDD)
Bi-polar disorder (BP)
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale
timeFrame: 6 and 12 months post-operatively
Secondary outcomes:
measure: 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
timeFrame: 6 and 12 months post operatively
measure: Post Cognitive Behavioural Therapy Scores
timeFrame: 15 months post operatively
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary & Alberta Health Services, Foothills Medical Centre
state: Alberta
Study officials:
affiliation: University of Calgary, Department of Clinical Neurosciences
name: Zelma H Kiss, MD PhDFRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary, Department of Psychiatry
name: Rajamannar Ramasubbu, MD MRCP FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramasubbu R, Clark DL, Golding S, Dobson KS, Mackie A, Haffenden A, Kiss ZH. Long versus short pulse width subcallosal cingulate stimulation for treatment-resistant depression: a randomised, double-blind, crossover trial. Lancet Psychiatry. 2020 Jan;7(1):29-40. doi: 10.1016/S2215-0366(19)30415-8.