Depressive Disorder, Treatment-ResistantCRIO-DBSNCT01983904
DBS for Treatment Resistant Depression
A study testing deep brain stimulation with short & long pulse width in people with Depressive Disorder, Treatment-Resistant, run by University of Calgary at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Depressive Disorder, Treatment-Resistant
- What is being tested?
- deep brain stimulation with short & long pulse width
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary & Alberta Health Services, Foothills Medical Centre
Calgary, Alberta, T2N 4Z6
About this study
Official title: Therapeutic Brain Stimulation for Refractory 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).
Read the detailed 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.
- Conditions
- Depressive Disorder, Treatment-Resistant
- Being tested
- deep brain stimulation with short & long pulse width
- Keywords
- Major depressive disorder (MDD), Bi-polar disorder (BP)
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulation with short & long pulse widthDevice
surgical implantation for bilateral electrodes and stimulation using short and long pulse width
| Study group | Role | What they receive |
|---|---|---|
| Long Pulse Width | Experimental | deep brain stimulation with short \& long pulse width Receives: Device: deep brain stimulation with short & long pulse width |
| Short Pulse Width | Experimental | deep brain stimulation with short \& long pulse width Receives: Device: deep brain stimulation with short & long pulse width |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
change in MADRS score from baseline before surgery to 6 and 12 months post operatively
Measured: 6 and 12 months post operatively
Post Cognitive Behavioural Therapy Scores
Changes in primary and secondary measures from pre-CBT scores will be used
Measured: 15 months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, Treatment-ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zelma Kiss, University of Calgary
- Investigators
- Zelma H Kiss, MD PhDFRCSC, Principal investigator, University of Calgary, Department of Clinical NeurosciencesRajamannar Ramasubbu, MD MRCP FRCP, Principal investigator, University of Calgary, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983904
- Sponsor's protocol ID
- E-20948
- Acronym
- CRIO-DBS
- Status last verified
- Apr 2019
- First submitted
- 7 Nov 2013
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
Publications
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.
PubMed 38185882Ramasubbu 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.
PubMed 31860455
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Brain Stimulation for Refractory Depression
- ClinicalTrials.gov ID
- NCT01983904
- Acronym / sponsor ID
- CRIO-DBS / E-20948
- Conditions
- Depressive Disorder, Treatment-Resistant
- Keywords
- Major depressive disorder (MDD), Bi-polar disorder (BP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long Pulse Width | Experimental | Device: deep brain stimulation with short & long pulse widthdeep brain stimulation with short \& long pulse width |
| Short Pulse Width | Experimental | Device: deep brain stimulation with short & long pulse widthdeep brain stimulation with short \& long pulse width |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep brain stimulation with short & long pulse widthsurgical implantation for bilateral electrodes and stimulation using short and long pulse width | Device | Long Pulse Width, Short Pulse Width |
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)
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 38185882Ramasubbu 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.
- Derived from this study: PubMed 31860455Ramasubbu 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.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zelma H Kiss, MD PhDFRCSC principal investigator
University of Calgary, Department of Clinical Neurosciences
Rajamannar Ramasubbu, MD MRCP FRCP principal investigator
University of Calgary, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep brain stimulation with short & long pulse width in people with Depressive Disorder, Treatment-Resistant, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (time frame: 6 and 12 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01983904, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.