DBS for Treatment Resistant Depression

Depressive Disorder, Treatment-Resistant Clinical Trial

— CRIO-DBS  

Official title:

Therapeutic Brain Stimulation for Refractory Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983904
• Other study ID #: E-20948
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: March 2018

Study information

• Verified date: April 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Intervention

Device:
• deep brain stimulation with short & long pulse width
surgical implantation for bilateral electrodes and stimulation using short and long pulse width

Locations

Country	Name	City	State
Canada	University of Calgary & Alberta Health Services, Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 and 12 months post-operatively
Secondary	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	6 and 12 months post operatively
Secondary	Post Cognitive Behavioural Therapy Scores	Changes in primary and secondary measures from pre-CBT scores will be used	15 months post operatively