DBS for Treatment Resistant Depression

Not Applicable

Completed

• Conditions: Depressive Disorder, Treatment-Resistant
• Interventions: Device: deep brain stimulation with short & long pulse width

• Registration Number: NCT01983904
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Primary Completion: 2017-12
• Study Completion: 2018-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Long Pulse Width	deep brain stimulation with short & long pulse width	deep brain stimulation with short \& long pulse width
Short Pulse Width	deep brain stimulation with short & long pulse width	deep brain stimulation with short \& long pulse width

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Calgary & Alberta Health Services, Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada