Major Depressive DisorderSTHYMNCT01973478
Deep Brain Stimulation in Patients With Chronic Treatment Resistant Depression
A study testing DBS in people with Major Depressive Disorder and Recurrent Depressive Disorder, run by Rennes University Hospital at 5 sites in France.
Trial summary
Major depressive disorders are real public health issues in terms of diagnosis and treatment. Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide risk is important. Patients with TRD are potential candidates for neurosurgical interventions to treat depression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Recurrent Depressive Disorder, Bipolar Disorder
- What is being tested?
- DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 5 sitesFrance
- Study dates
- 3 Jun 2014to 27 Nov 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- DSM-IV (DSM = Diagnostic and Statistical Manual) criteria for a recurrent depressive disorder or bipolar disorder
- Duration of the episode > 2 years
- Severity of the episode attested by :
- A HDRS score > 21
- A CGI score ≥ 4
Show all 40Show fewer
- A GAF < 50
- Persistence of severity criteria during the screening
- Following characteristics resistance in case of recurrent depressive disorder :
- Stage V of the classification of Thase and Rush
- Unsuccessful treatment by the association of two antidepressants (or intolerance/contra-indications)
- Unsuccessful treatment by the association for at least 6 weeks of one of the following treatments : lithium , thyroid hormone , buspirone , pindolol with an antidepressant (or intolerance/contra-indications)
- Unsuccessful treatment by the combination of a second-generation antipsychotic (olanzapine, risperidone, amisulpride, aripiprazole, clozapine and quetiapine) to an antidepressant (or intolerance/contra-indications)
- Unsuccessful treatment by a structured psychotherapy
- Following characteristics of resistance in case of bipolar disorder:
- Unsuccessful treatment by lithium (or intolerance/contra-indications)
- Unsuccessful treatment by at least one mood stabilizer anticonvulsant (or intolerance/contra-indications)
- Unsuccessful treatment by at least one second-generation antipsychotic (or intolerance/contra-indications)
- Unsuccessful treatment by the combination of two mood stabilizers with at least an anticonvulsant (or intolerance/contra-indications)
- Unsuccessful treatment by electro-convulsive therapy sessions (or intolerance/contra-indications)
- Unsuccessful treatment by at least one antidepressant , mood stabilizer combination (or intolerance/contra-indications)
- Unsuccessful treatment by a structured psychotherapy
- Understanding the conduct of the study
- Giving a written informed consent
- Benefiting from the french social insurance
- Non-Inclusion Criteria:
- Comorbid axis 1 disorder (except dysthymia, generalized anxiety disorder, social phobia, panic disorder)
- Alcohol or other psychoactive substances dependence (except nicotine)
- Suicidal risk during the last month assessed by the MINI (Mini International Neuropsychiatric Interview), the DIGS (Diagnostic Interview for Genetic Studies) and the item 3 of the HDRS
- Suicide attempt in the last 6 months or two suicide attempts in the previous two years
- History of forensic act or furious mania
- Depressive episode with congruent or incongruent psychotic features or history of a depressive episode with psychotic features
- Comorbid cluster A or B personality disorders according to the DSM IV-TR evaluated using the SCID2 (Structured Clinical Interview for DSM-IV)
- Cognitive Impairment (Mattis < 130)
- MRI (Magnetic Resonance Imaging) contraindication to stimulation or contraindications for MRI
- Major somatic disease making it impossible to set up the study treatment
- Pregnant women, or nursing or childbearing potential without effective contraception
- Involuntary commitment
- Guardianship
- Participation in another study
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
APHM
Marseille
APHP Pitié Salpetriere
Paris
CHS
Poitiers
CHS
Rouen
CHU
Toulouse
About this study
Major depressive disorders are real public health issues in terms of diagnosis and treatment. Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide risk is important.
Patients with TRD are potential candidates for neurosurgical interventions to treat depression. However, psychosurgery interventions based upon lesions, showed their limitations related to 1. the large variability in neurosurgical gestures, 2. their side effects, and of course 3. the irreversible damage caused by the surgery.
Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.
Read the detailed description
Because of their recurrent nature, their prevalence and their consequences, major depressive disorders are real public health issues in terms of diagnosis and treatment.
Some forms of depression are chronic and resistant to treatment (TRD), either unipolar (repeated episodes of depression) or bipolar (repeated episodes of depression and manic and/or hypomanic episodes). In these forms suicide risk is important.
Patients with TRD are potential candidates for neurosurgical interventions to treat depression. The benefit of neurosurgical procedures is expected to be important in these patients.
Psychosurgery interventions based upon lesions, however, showed their limitations related to 1/ the large variability in neurosurgical gestures, 2/ their side effects, and of course 3/ the irreversible damage caused by the surgery.
Current brain imaging data yielded fresh information about the pathophysiology of depression and suggested new therapeutic approaches in TRD.
Modulation of sub-caudate specific pathways, which are part of orbitofrontal and anterior cingulate cortico-subcortical loops should allow for a diminution of depressive symptoms.
The modulation of these specific pathways, initially targeted by classical neurosurgery, could benefit from current developments in functional neurosurgery.
Deep brain stimulation (DBS) may represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.
- Being tested
- DBS, SHAM
- Keywords
- Major depressive disorder, Recurrent depressive disorder, Bipolar disorder, Deep brain stimulation, Accumbens
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBSDevice
SHAMDevice
| Study group | Role | What they receive |
|---|---|---|
| DBS | Experimental | The medical device includes:
* Either a pacemaker ACTIVA PC (Ref 37601) two-channel (Medtronic USA) or two pacemakers Activa SC (Ref 37603) to a channel (Medtronic USA)
* Two DBS electrodes with four contacts (type Medtronic DBS 3389). Patients will be operated with the usual stereotactic surgical procedure.
The target is the Accumbens nucleus.
The two electrodes are implanted in a single session under local anaesthesia or intermittent sedation (propofol parenteral without intubation early intervention). Day 0 is defined by the surgery.
The DBS is "on" during 6 months (between Month 1 and Month 7). Stimulation will also be on after Month 7. Receives: Device: DBS |
| SHAM | Sham comparator | The medical device includes:
* Either a pacemaker ACTIVA PC (Ref 37601) two-channel (Medtronic USA) or two pacemakers Activa SC (Ref 37603) to a channel (Medtronic USA)
* Two DBS electrodes with four contacts (type Medtronic DBS 3389). Patients will be operated with the usual stereotactic surgical procedure.
The target is the Accumbens nucleus.
The two electrodes are implanted in a single session under local anaesthesia or intermittent sedation (propofol parenteral without intubation early intervention). Day 0 is defined by the surgery.
The DBS is "off" during 6 months (between Month 1 and Month 7). Possibility to active the stimulation after Month 7. Receives: Device: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response = 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version) (yes/no)
Response is defined as a 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version)
Measured: Month 7
Secondary outcomes (12)
Remission (yes/no)
Remission is defined as an HDRS-17 score < 7
Measured: Month 7
CGI (Clinical global impressions) amelioration (yes/no)
Score of 1 or 2 (item 2 of the CGI)
Measured: Month 7
GAF (Global assessment of functioning)
Presence of a score ≥ 60
Measured: Month 7
HDRS-17 (Hamilton depression rating scale, 17 items version)
Score
Measured: Month 7
MADRS (Montgomery-Asberg Depression Rating Scale)
Score
Measured: Month 7
BDI (Beck Depression Inventory)
Score
Measured: Month 7
CGI (Clinical global impressions)
Score
Measured: Month 7
LARS (Lille Apathy Rating scale)
Score
Measured: Month 7
GAF (Global assessment of functioning)
Score
Measured: Month 7
Neuropsychological assessment
Measured: Day -7 ; Month 1; Month 7; Month 13; Month 19; Month 24
Cerebral metabolism (PET scans)
Measured: Day -7; Month 7
Adverse events
Adverse events occuring during the study.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study start3 Jun 2014
- Primary completion3 Jul 2017
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Michel Reymann, Study chair, CIC INSERM 0203 CHU RennesFlorian Naudet, Study chair, CIC INSERM 0203 CHU RennesBruno Millet, Principal investigator, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973478
- Sponsor's protocol ID
- 35RC08_8902
- Acronym
- STHYM
- Status last verified
- Dec 2019
- First submitted
- 8 Oct 2013
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation in Patients With Chronic Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT01973478
- Acronym / sponsor ID
- STHYM / 35RC08_8902
- Keywords
- Major depressive disorder, Recurrent depressive disorder, Bipolar disorder, Deep brain stimulation, Accumbens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 3 Jun 2014 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 31 Oct 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.
Major depressive disorders are real public health issues in terms of diagnosis and treatment. Some forms of depression are chronic and resistant to treatment (TRD). In these forms suicide risk is important.
Patients with TRD are potential candidates for neurosurgical interventions to treat depression. However, psychosurgery interventions based upon lesions, showed their limitations related to 1. the large variability in neurosurgical gestures, 2. their side effects, and of course 3. the irreversible damage caused by the surgery.
Thus, deep brain stimulation (DBS) could represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.
Detailed description
Because of their recurrent nature, their prevalence and their consequences, major depressive disorders are real public health issues in terms of diagnosis and treatment.
Some forms of depression are chronic and resistant to treatment (TRD), either unipolar (repeated episodes of depression) or bipolar (repeated episodes of depression and manic and/or hypomanic episodes). In these forms suicide risk is important.
Patients with TRD are potential candidates for neurosurgical interventions to treat depression. The benefit of neurosurgical procedures is expected to be important in these patients.
Psychosurgery interventions based upon lesions, however, showed their limitations related to 1/ the large variability in neurosurgical gestures, 2/ their side effects, and of course 3/ the irreversible damage caused by the surgery.
Current brain imaging data yielded fresh information about the pathophysiology of depression and suggested new therapeutic approaches in TRD.
Modulation of sub-caudate specific pathways, which are part of orbitofrontal and anterior cingulate cortico-subcortical loops should allow for a diminution of depressive symptoms.
The modulation of these specific pathways, initially targeted by classical neurosurgery, could benefit from current developments in functional neurosurgery.
Deep brain stimulation (DBS) may represent an opportunity for patients suffering from TRD. Our preliminary study based upon the stimulation of the accumbens nucleus showed encouraging results. The investigators have thus planned a randomized controlled trial versus sham stimulation to confirm the therapeutic value of nucleus accumbens DBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBS | Experimental | Device: DBSThe medical device includes: * Either a pacemaker ACTIVA PC (Ref 37601) two-channel (Medtronic USA) or two pacemakers Activa SC (Ref 37603) to a channel (Medtronic USA) * Two DBS electrodes with four contacts (type Medtronic DBS 3389). Patients will be operated with the usual stereotactic surgical procedure. The target is the Accumbens nucleus. The two electrodes are implanted in a single session under local anaesthesia or intermittent sedation (propofol parenteral without intubation early intervention). Day 0 is defined by the surgery. The DBS is "on" during 6 months (between Month 1 and Month 7). Stimulation will also be on after Month 7. |
| SHAM | Sham comparator | Device: SHAMThe medical device includes: * Either a pacemaker ACTIVA PC (Ref 37601) two-channel (Medtronic USA) or two pacemakers Activa SC (Ref 37603) to a channel (Medtronic USA) * Two DBS electrodes with four contacts (type Medtronic DBS 3389). Patients will be operated with the usual stereotactic surgical procedure. The target is the Accumbens nucleus. The two electrodes are implanted in a single session under local anaesthesia or intermittent sedation (propofol parenteral without intubation early intervention). Day 0 is defined by the surgery. The DBS is "off" during 6 months (between Month 1 and Month 7). Possibility to active the stimulation after Month 7. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Age between 18 and 70 years
- DSM-IV (DSM = Diagnostic and Statistical Manual) criteria for a recurrent depressive disorder or bipolar disorder
- Duration of the episode > 2 years
- Severity of the episode attested by :
- Persistence of severity criteria during the screening
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DBS | Device | DBS |
| SHAM | Device | SHAM |
Primary outcome
Response = 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version) (yes/no)
Time frame: Month 7
Response is defined as a 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version)
12 secondary outcomes
Remission (yes/no)
Time frame: Month 7
CGI (Clinical global impressions) amelioration (yes/no)
Time frame: Month 7
GAF (Global assessment of functioning)
Time frame: Month 7
HDRS-17 (Hamilton depression rating scale, 17 items version)
Time frame: Month 7
MADRS (Montgomery-Asberg Depression Rating Scale)
Time frame: Month 7
BDI (Beck Depression Inventory)
Time frame: Month 7
CGI (Clinical global impressions)
Time frame: Month 7
LARS (Lille Apathy Rating scale)
Time frame: Month 7
GAF (Global assessment of functioning)
Time frame: Month 7
Neuropsychological assessment
Time frame: Day -7 ; Month 1; Month 7; Month 13; Month 19; Month 24
Cerebral metabolism (PET scans)
Time frame: Day -7; Month 7
Adverse events
Time frame: Month 24
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 27 Dec 2019.
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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.
Jean Michel Reymann study chair
CIC INSERM 0203 CHU Rennes
Florian Naudet study chair
CIC INSERM 0203 CHU Rennes
Bruno Millet principal investigator
Groupe Hospitalier Pitie-Salpetriere
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS in people with Major Depressive Disorder and Recurrent Depressive Disorder, run by Rennes University Hospital at 5 sites in France.
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 40 inclusion and 0 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 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
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?
Response = 50 % decrease of the HDRS-17 (Hamilton depression rating scale, 17 items version) (yes/no) (time frame: Month 7). 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 27 Dec 2019.