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Completed

NCT Number: NCT01983904

DBS for Treatment Resistant Depression

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).

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Key information

Conditions

Depressive Disorder, Treatment-Resistant Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary & Alberta Health Services, Foothills Medical Centre

Calgary, Alberta, T2N 4Z6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

deep brain stimulation with short & long pulse width

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Therapeutic Brain Stimulation for Refractory Depression

Acronym: CRIO-DBS

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Nov 14, 2013
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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