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DBS for Treatment Resistant Depression (CRIO-DBS)

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ClinicalTrials.gov Identifier: NCT01983904
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Zelma Kiss, University of Calgary

Tracking Information
First Submitted Date  ICMJE November 7, 2013
First Posted Date  ICMJE November 14, 2013
Last Update Posted Date April 18, 2019
Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
Change in Hamilton Depression Rating Scale [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
  • 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 [ Time Frame: 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 [ Time Frame: 15 months post operatively ]
    Changes in primary and secondary measures from pre-CBT scores will be used
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
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 [ Time Frame: 6 and 12 months post operatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 7, 2013)
Post Cognitive Behavioural Therapy Scores [ Time Frame: 15 months post operatively ]
changes in primary and secondary measures from pre-CBT scores will be used
 
Descriptive Information
Brief Title  ICMJE DBS for Treatment Resistant Depression
Official Title  ICMJE Therapeutic Brain Stimulation for Refractory Depression
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Treatment-Resistant
Intervention  ICMJE Device: deep brain stimulation with short & long pulse width
surgical implantation for bilateral electrodes and stimulation using short and long pulse width
Study Arms  ICMJE
  • Experimental: Long Pulse Width
    deep brain stimulation with short & long pulse width
    Intervention: Device: deep brain stimulation with short & long pulse width
  • Experimental: Short Pulse Width
    deep brain stimulation with short & long pulse width
    Intervention: Device: deep brain stimulation with short & long pulse width
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
22
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2013)
25
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01983904
Other Study ID Numbers  ICMJE E-20948
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: undecided
Responsible Party Zelma Kiss, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zelma H Kiss, MD PhDFRCSC University of Calgary, Department of Clinical Neurosciences
Principal Investigator: Rajamannar Ramasubbu, MD MRCP FRCP University of Calgary, Department of Psychiatry
PRS Account University of Calgary
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP