DBS for Treatment Resistant Depression

NCT01983904 | Completed

• 1 other identifier: E-20948
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Depressive Disorder, Treatment-Resistant

Keywords

Major depressive disorder (MDD); Bi-polar disorder (BP)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  6 and 12 months post operatively

• Post Cognitive Behavioural Therapy Scores

  15 months post operatively

Study Arms (2)

Long Pulse Width

EXPERIMENTAL

deep brain stimulation with short \& long pulse width

Device: deep brain stimulation with short & long pulse width

Short Pulse Width

EXPERIMENTAL

deep brain stimulation with short \& long pulse width

Device: deep brain stimulation with short & long pulse width

Interventions

deep brain stimulation with short & long pulse width DEVICE

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

Long Pulse Width; Short Pulse Width

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary & Alberta Health Services, Foothills Medical Centre

Calgary, Alberta, T2N 4Z6, Canada

Location

Related Publications (2)

• Ramasubbu R, Brown EC, Mouches P, Moore JA, Clark DL, Molnar CP, Kiss ZHT, Forkert ND. Multimodal imaging measures in the prediction of clinical response to deep brain stimulation for refractory depression: A machine learning approach. World J Biol Psychiatry. 2024 Mar;25(3):175-187. doi: 10.1080/15622975.2023.2300795. Epub 2024 Jan 17.

  PMID: 38185882 DERIVED

• 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.

  PMID: 31860455 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major; Bipolar Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neurosurgery; Director Clinician Investigator Program

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

CA (1)