Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2013-08-31
2018-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD)
NCT01898429
Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression
NCT03952962
Deep Brain Stimulation for Treatment Resistant Depression
NCT00367003
Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression
NCT03360942
DBS for Depression
NCT03437928
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Long Pulse Width
deep brain stimulation with short \& long pulse width
deep brain stimulation with short & long pulse width
surgical implantation for bilateral electrodes and stimulation using short and long pulse width
Short Pulse Width
deep brain stimulation with short \& long pulse width
deep brain stimulation with short & long pulse width
surgical implantation for bilateral electrodes and stimulation using short and long pulse width
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
deep brain stimulation with short & long pulse width
surgical implantation for bilateral electrodes and stimulation using short and long pulse width
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Calgary
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zelma Kiss
Associate Professor, Neurosurgery; Director Clinician Investigator Program
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zelma H Kiss, MD PhDFRCSC
Role: PRINCIPAL_INVESTIGATOR
University of Calgary, Department of Clinical Neurosciences
Rajamannar Ramasubbu, MD MRCP FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Calgary, Department of Psychiatry
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Calgary & Alberta Health Services, Foothills Medical Centre
Calgary, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E-20948
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.