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DBS for Treatment Resistant Depression (CRIO-DBS)

Primary Purpose

Depressive Disorder, Treatment-Resistant

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

deep brain stimulation with short & long pulse width

About this trial

This is an interventional treatment trial for Depressive Disorder, Treatment-Resistant focused on measuring Major depressive disorder (MDD), Bi-polar disorder (BP)

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Calgary & Alberta Health Services, Foothills Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Long Pulse Width

Short Pulse Width

Arm Description

deep brain stimulation with short & long pulse width

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Post Cognitive Behavioural Therapy Scores

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

Full Information

NCT ID

NCT01983904

First Posted

November 7, 2013

Last Updated

April 16, 2019

Sponsor

University of Calgary

1. Study Identification

Unique Protocol Identification Number

NCT01983904

Brief Title

DBS for Treatment Resistant Depression

Acronym

CRIO-DBS

Official Title

Therapeutic Brain Stimulation for Refractory Depression

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Calgary

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Treatment-Resistant

Keywords

Major depressive disorder (MDD), Bi-polar disorder (BP)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Long Pulse Width

Arm Type

Experimental

Arm Description

deep brain stimulation with short & long pulse width

Arm Title

Short Pulse Width

Arm Type

Experimental

Arm Description

deep brain stimulation with short & long pulse width

Intervention Type

Device

Intervention Name(s)

deep brain stimulation with short & long pulse width

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Hamilton Depression Rating Scale

Description

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 Outcome Measure Information:

Title

Description

change in MADRS score from baseline before surgery to 6 and 12 months post operatively

Time Frame

6 and 12 months post operatively

Title

Post Cognitive Behavioural Therapy Scores

Description

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

Time Frame

15 months post operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zelma H Kiss, MD PhDFRCSC

Organizational Affiliation

University of Calgary, Department of Clinical Neurosciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rajamannar Ramasubbu, MD MRCP FRCP

Organizational Affiliation

University of Calgary, Department of Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Calgary & Alberta Health Services, Foothills Medical Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

undecided

Citations:

PubMed Identifier

31860455

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.

Results Reference

derived

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DBS for Treatment Resistant Depression

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