Clinical Trial: DBS for Treatment Resistant Depression

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: University of Calgary

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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: 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 ]

Information By: University of Calgary

Dates:
Date Received: November 7, 2013
Date Started: August 2013
Date Completion: March 2018
Last Updated: October 26, 2016
Last Verified: October 2016