Treatment Resistant DepressionNCT01801319
A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression
A study testing Libra Deep Brain Stimulation System in people with Treatment Resistant Depression and Depressive Disorder, run by Abbott Medical Devices at 1 site in Canada.
Trial summary
This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety, efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate Gyrus Deep Brain Stimulation (SCG DBS) for participants with Treatment-Resistant Depression (TRD). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Treatment Resistant Depression, Depressive Disorder
- What is being tested?
- Libra Deep Brain Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Dec 2017
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (non-pregnant) ages 21-70 years;
- Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria;
- First episode onset before age 45;
- Current episode > 12 months duration;
- In the current episode: Documented resistance (i.e. persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's, SNRI's, TCA's, MAO-inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score of at least 3 according to the amended Antidepressant Treatment History Form (ATHF) criteria;
- Hamilton Depression Rating Scale (HDRS) of > 20 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 HDRS scores cannot improve ≥ 25%;
Who cannot join
- A diagnosis of a bipolar I or bipolar II disorder by DSM-IV-TR criteria;
- Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality.
- In the current depressive episode, has been diagnosed with General Anxiety Disorder (GAD) - as defined by the DSM-IV-TR, and GAD is the primary diagnosis;
- Has an intracranial Central Nervous System (CNS) disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson's Disease, migraine, stroke, Huntington's, head trauma, etc.) with exception to non-migraine headaches;
- Has been diagnosed with fibromyalgia or has a current condition which requires chronic pain narcotic usage (e.g. morphine, methadone);
- Has been currently diagnosed with chronic fatigue syndrome;
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- Substantial suicidal risk as defined by (1) a current plan and intent, (2) clinician judgment that there is a clear immediate intent for self-harm, (3) more than 3 suicide attempts within the last 12 months;
- Co-morbid obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, bulimia or anorexia nervosa if previously present, must be in remission for 6 months as defined by DSM-IV-TR criteria, derived from the MINI;
- Alcohol, medication, or illegal substance dependence within last 12 months;
- Advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon;
- Plans to use diathermy;
- Have any metallic implants in the brain such as aneurysm clips or cochlear implants;
- Currently participating in another investigational device, drug or surgical trial.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety, efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate Gyrus Deep Brain Stimulation (SCG DBS) for participants with Treatment-Resistant Depression (TRD). A total of 40 eligible participants will be randomized to four treatment sequences (10 participants per sequence). Each participant will be treated over a 6-month period with active or sham stimulation in which both the participants and the attending psychiatrists will be blinded to treatment allocation.
- Being tested
- Libra Deep Brain Stimulation System
- Keywords
- major depressive disorder (MDD), deep brain stimulation (DBS), subcallosal cingulate gyrus, Therapy-Resistant Depression, Electrical Stimulation of the Brain, Brain Stimulation, Deep
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Libra Deep Brain Stimulation SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Active comparator | Libra Deep Brain Stimulation System is implanted and activated post implantation Receives: Device: Libra Deep Brain Stimulation System |
| No Stimulation | Sham comparator | The Libra DBS System is implanted and not activated Receives: Device: Libra Deep Brain Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy: Changes in the Hamilton Depression Rating Scale-17
evaluate change in HAMD-17 3 months and 6 months after implantation
Measured: 3 and 6 months
Secondary outcomes (2)
The incidence of all adverse events
The incidence of all adverse events (i.e. hospitalization due to worsening depression, suicidal ideation, or behavior, medical treatment, and device related events) that occur over study duration.
Measured: 6 months
Showing SCG-DBS significantly increases health related quality of life compared to sham stimulation in patients with TRD
The following health related quality of life measures will be evaluated: Sheehan Disability Scale-Visual Analog Scale (SDS-VAS), Short Form-12 (SF-12), Sexual Functioning questionnaire (SEX FX) and Endicott Work Productivity Scale (EWPS). Each measure will be evaluated at baseline and the after each treatment period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startJun 2011
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sidney Kennedy, M.D., Principal investigator, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801319
- Sponsor's protocol ID
- C-08-07
- Other IDs
- Health Canada 148956
- Status last verified
- Apr 2017
- First submitted
- 26 Feb 2013
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT01801319
- Acronym / sponsor ID
- C-08-07
- Keywords
- major depressive disorder (MDD), deep brain stimulation (DBS), subcallosal cingulate gyrus, Therapy-Resistant Depression, Electrical Stimulation of the Brain, Brain Stimulation, Deep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Feb 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.
This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety, efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate Gyrus Deep Brain Stimulation (SCG DBS) for participants with Treatment-Resistant Depression (TRD). A total of 40 eligible participants will be randomized to four treatment sequences (10 participants per sequence). Each participant will be treated over a 6-month period with active or sham stimulation in which both the participants and the attending psychiatrists will be blinded to treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Active comparator | Device: Libra Deep Brain Stimulation SystemLibra Deep Brain Stimulation System is implanted and activated post implantation |
| No Stimulation | Sham comparator | Device: Libra Deep Brain Stimulation SystemThe Libra DBS System is implanted and not activated |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women (non-pregnant) ages 21-70 years;
- Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria;
- First episode onset before age 45;
- Current episode > 12 months duration;
- In the current episode: Documented resistance (i.e. persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's, SNRI's, TCA's, MAO-inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score of at least 3 according to the amended Antidepressant Treatment History Form (ATHF) criteria;
Key exclusion criteria (13 listed)
- A diagnosis of a bipolar I or bipolar II disorder by DSM-IV-TR criteria;
- Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality.
- In the current depressive episode, has been diagnosed with General Anxiety Disorder (GAD) - as defined by the DSM-IV-TR, and GAD is the primary diagnosis;
- Has an intracranial Central Nervous System (CNS) disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson's Disease, migraine, stroke, Huntington's, head trauma, etc.) with exception to non-migraine headaches;
- Has been diagnosed with fibromyalgia or has a current condition which requires chronic pain narcotic usage (e.g. morphine, methadone);
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 |
|---|---|---|
| Libra Deep Brain Stimulation System | Device | No Stimulation, Stimulation |
Primary outcome
Primary Efficacy: Changes in the Hamilton Depression Rating Scale-17
Time frame: 3 and 6 months
evaluate change in HAMD-17 3 months and 6 months after implantation
2 secondary outcomes
The incidence of all adverse events
Time frame: 6 months
Showing SCG-DBS significantly increases health related quality of life compared to sham stimulation in patients with TRD
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
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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.
Sidney Kennedy, M.D. principal investigator
Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Libra Deep Brain Stimulation System in people with Treatment Resistant Depression and Depressive Disorder, run by Abbott Medical Devices 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Apr 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Primary Efficacy: Changes in the Hamilton Depression Rating Scale-17 (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2017.