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Trial record 4 of 201 for:    Depressive Disorder | "Depressive Disorder, Treatment-Resistant"

DBS for Treatment Resistant Depression (CRIO-DBS)

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ClinicalTrials.gov Identifier: NCT01983904
Recruitment Status : Active, not recruiting
First Posted : November 14, 2013
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Zelma Kiss, 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).


Condition or disease Intervention/treatment Phase
Depressive Disorder, Treatment-Resistant Device: deep brain stimulation with short & long pulse width Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Brain Stimulation for Refractory Depression
Study Start Date : August 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Long Pulse Width
deep brain stimulation with short & long pulse width
Device: deep brain stimulation with short & long pulse width
surgical implantation for bilateral electrodes and stimulation using short and long pulse width

Experimental: Short Pulse Width
deep brain stimulation with short & long pulse width
Device: deep brain stimulation with short & long pulse width
surgical implantation for bilateral electrodes and stimulation using short and long pulse width




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Post Cognitive Behavioural Therapy Scores [ Time Frame: 15 months post operatively ]
    Changes in primary and secondary measures from pre-CBT scores will be used



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983904


Locations
Canada, Alberta
University of Calgary & Alberta Health Services, Foothills Medical Centre
Calgary, Alberta, Canada, T2N 4Z6
Sponsors and Collaborators
University of Calgary
Investigators
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

Responsible Party: Zelma Kiss, Associate Professor, Neurosurgery; Director Clinician Investigator Program, University of Calgary
ClinicalTrials.gov Identifier: NCT01983904     History of Changes
Other Study ID Numbers: E-20948
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

Keywords provided by Zelma Kiss, University of Calgary:
Major depressive disorder (MDD)
Bi-polar disorder (BP)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders