Major Depressive Disorder, Recurrent, UnspecifiedPRESTHYMNCT01569711
Deep Brain Stimulation of Nucleus Accumbens for Chronic and Resistant Major Depressive Disorder
An observational study of Major Depressive Disorder, Recurrent, Unspecified, run by Rennes University Hospital at 10 sites in France.
Trial summary
Depression is a common, recurrent and disabling disorder. Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients, 50% would not benefit from electroconvulsive therapy (ECT). Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Major Depressive Disorder, Recurrent, Unspecified
- What is being tested?
- Deep brain stimulation of nucleus accumbens
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 10 sitesFrance
- Study dates
- Feb 2009to May 2013
- Phase
- Observational
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with a chronic and resistant major depressive disorder.
Who may be able to join
- Patients between 30 and 60 years old
- Meeting DSM-IV-TR for a major depressive disorder (MDD), recurrent (296.3x) diagnosed using the MINI scale
- Duration of the episode > 2 years
- History of recurrent MDD (at least one prior episode index), authenticated by a report of ambulatory care or hospitalization
- Meeting Thase and Rush stage V for resistance (Thase and Rush 1997) (Annex 1 : mettre l'annexe)
- Presenting simultaneously an HDRS total score (17 items)> 21, a GAF <50, and a score of 4 on CGI despite the use of all the following strategies :
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- monotherapy: 2 SSRIs, 1 ISRNA, 1 tricyclic (with measurement of plasma) at the maximum prescribed for a period of 8 weeks
- association at least one previous antidepressant, and for at least six weeks of one of the following treatment: lithium, thyroid hormone, buspirone, pindolol. An intolerance to one of these drug treatments related to its known side effects will be considered equivalent to the lack of effect of this treatment
- irreversible MAOI: iproniazid (Marsilid *)
- combination of 2 antipsychotics, with at least a second generation antipsychotic (olanzapine, risperidone, amisulpride, aripiprazole or clozapine)
- combination of 2 antidepressants
- ECT: at least 8 sessions in maximal load with crisis GET> 25 sec bilaterally. If not possible by cognitive impairment: unilateral
- structured psychotherapy inspired cognitive-behavioral or other type of structured psychotherapy for a period of one year
- Understanding of the study
- Giving their written, free and informed consent
- Affiliated to social security
Who cannot join
- Serious and unstable medical condition (cardiovascular, respiratory, endocrine, metabolic, liver, renal, hematologic, infectious, neurological or other ...) making impossible the establishment of study treatment
- Cognitive deterioration (Mattis < 130)
- Abnormal brain standard MRI or contraindication for MRI
- Axis 1 disorder other than MDD (except generalized anxiety disorder, social phobia, panic disorder)
- Addiction to alcohol and other psychoactive substances with the exception of nicotine
- suicide risk in the last month (MINI 5.0.0: section suicide risk DIGS: section intent, premeditation, lethality) and score> 2 in item 3 of HDRS
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- More than two suicide attempts within two years prior to inclusion
- MDD with psychotic features congruent or incongruent to the mood or an history of MDD with psychotic features
- Diagnostic criteria for personality disorders according to DSM-IV-TR Cluster A or B evaluated using the SCID2 (Maffei et al., 1997)
- Involuntary commitment, guardianship or trusteeship
- Women of childbearing without effective contraception
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Bordeaux UH
Bordeaux, 33076
Gabriel montpied University Hospital
Clermont-Ferrand, 63003
Grenoble University Hospital (Nord Hospital)
Grenoble, France, 38043
Lille UH (Roger Salengro Hospital)
Lille, 59037
Lyon UH (Pierre Wertheimer Hospital)
Lyon, 69394
La Salpétrière UH
Paris, 75013
Sainte Anne UH
Paris, 75014
Poitiers UH
Poitiers, 86021
Rennes UH
Rennes, 35703
Toulouse UH
Toulouse, 31059
About this study
Official title: Preliminary Study Evaluating Deep Brain Stimulation of Nucleus Accumbens in Patients Suffering From Chronic and Resistant Major Depressive Disorder
Depression is a common, recurrent and disabling disorder. Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients, 50% would not benefit from electroconvulsive therapy (ECT). For such patients, deep brain stimulation (DBS) of nucleus accumbens is considered.
Read the detailed description
Depression is a common (12-Month Prevalence in the general population: 6%), recurrent and disabling disorder.
Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients not responding favorably to antidepressant medications, 50% would not benefit from ECT. For such patients, surgical interventions have been proposed in the past.
Many results support the hypothesis of a dysfunction of the functional loops between cortical and subcortical structures underlying the expression of depressive disorders.
Thus, therapeutic intervention focusing on these loops, in patients with chronic depression resistant to treatment, should be an issue and could improve prognosis of these patients.
As part of a maximal resistance to antidepressant drug, after failure of a series of bilateral ECT, a surgical functional intervention using DBS of nucleus accumbens is considered.
This open-label trial proposes to assess feasibility, safety and efficacy of DBS of nucleus accumbens in patients with chronic depression.
- Being tested
- Deep brain stimulation of nucleus accumbens
- Keywords
- chronic and resistant major depressive disorder, deep brain stimulation
- Medical subject headings
- Depressive Disorder, Major, Recurrence, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation of nucleus accumbensProcedure or surgery
Also called Non applicable.
- Day0 : surgical placement of electrodes
- M1 : stimulation of nucleus accumbens
- M5 : stimulation of nucleus accumbens or associative territory of caudate nucleus (if no response observed with nucleus accumbens stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulation | Not described Receives: Procedure: Deep brain stimulation of nucleus accumbens |
What is being measured
The primary outcome is the main question the study is designed to answer.
response after four months (M5) of DBS months defined as a 50% decrease in HDRS score
The primary outcome is response after four months (M5) of DBS months defined as a 50% decrease in HDRS score.
Measured: At 5 months after the DBS
Secondary outcomes (8)
Remission (defined as a score in the HDRS ≤ 7) after 4 months
Measured: At 5 months after the DBS
Duration of remission in the year of postoperative follow-up
Measured: at one year of postoperative follow-up
Obtaining an overall score on the scale Anxiety Hamilton (HARS) ≤ 10 during the year of postoperative follow-up
Measured: at one year of postoperative follow-up
Getting a score from 1 ("very much improved") or 2 ("strongly improved ") to item 2 of the Clinical Global Impression (CGI) during the year of postoperative follow-up
Measured: at one year of postoperative follow-up
Obtaining a score ≥ 60 at the level of Global Assessment of Functioning (GAF) during the year of postoperative follow-up
Measured: at one year of postoperative follow-up
Changes in score on the scale of social adjustment in its self-assessment by (SAS-SR) in the year of postoperative follow-up
Measured: at one year of postoperative follow-up
Evaluation of tolerance to treatment by clinicians, and by the patient and his family circle, reporting by the patient for adverse events at each follow-up visits after surgery, completion of the initial neuropsychological checkup
Measured: at each follow-up visits after surgery
Effect of DBS at M9 after the DBS on caudate nucleus in case of non response at M5 after the DBS.
The same scales (as described before) will be used at M9, to describe the effect of DBS on caudate nucleus.
Measured: at 9 months after the DBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startFeb 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder, Recurrent, UnspecifiedStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Millet MD Bruno, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569711
- Sponsor's protocol ID
- 2008-A00234-51
- Acronym
- PRESTHYM
- Status last verified
- May 2015
- First submitted
- 24 Feb 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Millet B, Jaafari N, Polosan M, Baup N, Giordana B, Haegelen C, Chabardes S, Fontaine D, Devaux B, Yelnik J, Fossati P, Aouizerate B, Krebs MO, Robert G, Jay T, Cornu P, Verin M, Drapier S, Drapier D, Sauleau P, Peron J, Le Jeune F, Naudet F, Reymann JM. Limbic versus cognitive target for deep brain stimulation in treatment-resistant depression: accumbens more promising than caudate. Eur Neuropsychopharmacol. 2014 Aug;24(8):1229-39. doi: 10.1016/j.euroneuro.2014.05.006. Epub 2014 May 20.
PubMed 24950819
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study Evaluating Deep Brain Stimulation of Nucleus Accumbens in Patients Suffering From Chronic and Resistant Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01569711
- Acronym / sponsor ID
- PRESTHYM / 2008-A00234-51
- Keywords
- chronic and resistant major depressive disorder, deep brain stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Apr 2012 (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.
Depression is a common, recurrent and disabling disorder. Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients, 50% would not benefit from electroconvulsive therapy (ECT). For such patients, deep brain stimulation (DBS) of nucleus accumbens is considered.
Detailed description
Depression is a common (12-Month Prevalence in the general population: 6%), recurrent and disabling disorder.
Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients not responding favorably to antidepressant medications, 50% would not benefit from ECT. For such patients, surgical interventions have been proposed in the past.
Many results support the hypothesis of a dysfunction of the functional loops between cortical and subcortical structures underlying the expression of depressive disorders.
Thus, therapeutic intervention focusing on these loops, in patients with chronic depression resistant to treatment, should be an issue and could improve prognosis of these patients.
As part of a maximal resistance to antidepressant drug, after failure of a series of bilateral ECT, a surgical functional intervention using DBS of nucleus accumbens is considered.
This open-label trial proposes to assess feasibility, safety and efficacy of DBS of nucleus accumbens in patients with chronic depression.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep brain stimulation | – | Procedure: Deep brain stimulation of nucleus accumbens |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with a chronic and resistant major depressive disorder.
Key inclusion criteria (16 listed)
- Patients between 30 and 60 years old
- Meeting DSM-IV-TR for a major depressive disorder (MDD), recurrent (296.3x) diagnosed using the MINI scale
- Duration of the episode > 2 years
- History of recurrent MDD (at least one prior episode index), authenticated by a report of ambulatory care or hospitalization
- Meeting Thase and Rush stage V for resistance (Thase and Rush 1997) (Annex 1 : mettre l'annexe)
Key exclusion criteria (11 listed)
- Serious and unstable medical condition (cardiovascular, respiratory, endocrine, metabolic, liver, renal, hematologic, infectious, neurological or other ...) making impossible the establishment of study treatment
- Cognitive deterioration (Mattis < 130)
- Abnormal brain standard MRI or contraindication for MRI
- Axis 1 disorder other than MDD (except generalized anxiety disorder, social phobia, panic disorder)
- Addiction to alcohol and other psychoactive substances with the exception of nicotine
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 of nucleus accumbensAlso: Non applicable.* Day0 : surgical placement of electrodes * M1 : stimulation of nucleus accumbens * M5 : stimulation of nucleus accumbens or associative territory of caudate nucleus (if no response observed with nucleus accumbens stimulation) | Procedure or surgery | Deep brain stimulation |
Primary outcome
response after four months (M5) of DBS months defined as a 50% decrease in HDRS score
Time frame: At 5 months after the DBS
The primary outcome is response after four months (M5) of DBS months defined as a 50% decrease in HDRS score.
8 secondary outcomes
Remission (defined as a score in the HDRS ≤ 7) after 4 months
Time frame: At 5 months after the DBS
Duration of remission in the year of postoperative follow-up
Time frame: at one year of postoperative follow-up
Obtaining an overall score on the scale Anxiety Hamilton (HARS) ≤ 10 during the year of postoperative follow-up
Time frame: at one year of postoperative follow-up
Getting a score from 1 ("very much improved") or 2 ("strongly improved ") to item 2 of the Clinical Global Impression (CGI) during the year of postoperative follow-up
Time frame: at one year of postoperative follow-up
Obtaining a score ≥ 60 at the level of Global Assessment of Functioning (GAF) during the year of postoperative follow-up
Time frame: at one year of postoperative follow-up
Changes in score on the scale of social adjustment in its self-assessment by (SAS-SR) in the year of postoperative follow-up
Time frame: at one year of postoperative follow-up
Evaluation of tolerance to treatment by clinicians, and by the patient and his family circle, reporting by the patient for adverse events at each follow-up visits after surgery, completion of the initial neuropsychological checkup
Time frame: at each follow-up visits after surgery
Effect of DBS at M9 after the DBS on caudate nucleus in case of non response at M5 after the DBS.
Time frame: at 9 months after the DBS
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 May 2015.
- Derived from this study: PubMed 24950819Millet B, Jaafari N, Polosan M, Baup N, Giordana B, Haegelen C, Chabardes S, Fontaine D, Devaux B, Yelnik J, Fossati P, Aouizerate B, Krebs MO, Robert G, Jay T, Cornu P, Verin M, Drapier S, Drapier D, Sauleau P, Peron J, Le Jeune F, Naudet F, Reymann JM. Limbic versus cognitive target for deep brain stimulation in treatment-resistant depression: accumbens more promising than caudate. Eur Neuropsychopharmacol. 2014 Aug;24(8):1229-39. doi: 10.1016/j.euroneuro.2014.05.006. Epub 2014 May 20.
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.
Millet MD Bruno principal investigator
Rennes University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, Recurrent, Unspecified, run by Rennes University Hospital at 10 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 16 inclusion and 11 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 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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 after four months (M5) of DBS months defined as a 50% decrease in HDRS score (time frame: At 5 months after the DBS). 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 NCT01569711, which also lists 1 linked publication.
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 May 2015.