DepressionCG25NCT01834560
SubGenual CG25 Deep Brain Stimulation in Severe Resistant Depression
An observational study of Depression, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Despite the availability of several treatments, a number of patients with major depression are refractory to therapeutical approaches and therefore suffer from chronic handicap. For these severe patients, neurosurgical therapies can be envisaged. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Depression
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2007to Dec 2017
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients suffering from severe depression and referred by the psychiatry department of french University Hospital
Who may be able to join
- Men and women between 30 and 55 years old
- Women at a reproductive age will have to be under successful contraceptive and will undergo a pregnancy test before inclusion
- Patient suffering from major unipolar depression refractory to conventional therapies
- Chronic depression with ongoing depressive episode > 12 months.
- 4 unsuccessful therapies attempted to treat the ongoing episode, including anti-depressant monotherapies, potentialisation of antidepressant treatments, validated structured psychotherapies, electro-convulsive therapy performed accordingly to ANAES ( Agence Nationale d'Accréditation et d'Evaluation en Santé-the French Health Authority) recommendations (at least 6 sessions with bilateral technique and length control of convulsive crisis).
- Ambulatory or hospital care
Show all 9Show fewer
- Able to speak French, understand study procedures and complete questionnaires.
- Covered by french social health system
- Living in Rhone-Alpes area without plan to move in the next 2 years
Who cannot join
- History of cerebral surgery
- Neurological disorder that can interfere with evaluation of surgical procedure or significant cognitive impairment (Mattis score < 30)
- Psychiatric disorder responsible for comorbidity with the major depressive episode (schizophrenia and other delirium, diagnosed anxiety except generalized anxiety disorder, substance dependency)
- Personality disorder of A and B clusters
- Suicidal ideas at evaluation, intention for auto-destruction, repeated suicidal attempts in the last 3 years with emergency care or hospitalization
- Severe somatic pathology or contraindication to surgery due to heart defibrillator/pacemaker or other implanted device.
Show all 9Show fewer
- A decrease superior to or equal to 20% in the 17-Hamilton Depression Rating Scale score between inclusion and pre-surgery evaluation
- Drug dependency including alcohol in the last 12 months with history of abuse in the last 6 months, with the exception of nicotine
- Persons protected by the law.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subgenual Cingulate Stimulation in Resistant Depression
Despite the availability of several treatments, a number of patients with major depression are refractory to therapeutical approaches and therefore suffer from chronic handicap. For these severe patients, neurosurgical therapies can be envisaged. They aim at interrupting bundles that link the orbitofrontal cortex with striatum and can therefore benefit for the patients.
This study intends to repeat Dr. Lozano's study, published in 2005 in the journal Neuron. In this study, they performed a preliminary evaluation of chronic deep brain stimulation (DBS) of the subgenual cingulate region (Brodmann area 25) to treat refractory depression as an alternative to subcaudate tractotomy. This last technique was employed in Grenoble in the 60s with satisfying results before neurosurgery for psychiatric disorders was abandoned. Since 1992, psychosurgical therapies that respect ethical recommendations have regained interest to treat highly impaired patients. Before the investigators can propose deep brain stimulation of subgenual cingulate brain region as a new therapeutic approach for the investigators patients in Grenoble, the investigators decided to reproduce their clinical evaluation on a group of 6 patients, repeating their methodology faithfully. Therefore nothing was changed to the model used by Drs. Lozano and Mayberg and the investigators took advantage of the investigators own expertise regarding deep brain stimulation and subcaudate tractotomy.
Protocol is strictly identical to the one of Mayberg and Lozano in order to confirm their preliminary results. Cartography of physiological consequences of this procedure will be assessed by measuring cerebral blood flow by PET scan (positron emission tomography). Patients will be monitored and thoroughly assessed during including psychiatric, neurological, neurosurgical, neuropsychological and PET scan exams to measure treatment efficacy and potential adverse reactions. Patients will be followed for two more years to assess medium-term complications. This study will be a first step toward further research including potentially a multicentric clinical trial.
Read the detailed description
The protocol involves assessment of effects of CG25 (subgenual cingulate area-Brodmann 25) DBS on mood, anxiety, apathy, anhedonia, psychomotor retardation, functional state as well as safety and tolerance by specific psychometric scores.
Moreover the protocol aims at highlighting the neurocircuits modulated by CG25 DBS by means of PET (positron emission tomography) imagery
- Conditions
- Depression
- Keywords
- deep brain stimulation, subgenual cortex (CG25)
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of the Score at the Hamilton Depression Rating Scale
Measured: baseline, at 1 year
Secondary outcomes (1)
neurological examination
Measured: monthly during the first 6 mo and every 3 months until the end of the 1st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startDec 2007
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Chabardes, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834560
- Sponsor's protocol ID
- CG25
- Acronym
- CG25
- Status last verified
- Oct 2018
- First submitted
- 21 Mar 2013
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subgenual Cingulate Stimulation in Resistant Depression
- ClinicalTrials.gov ID
- NCT01834560
- Acronym / sponsor ID
- CG25 / CG25
- Conditions
- Depression
- Keywords
- deep brain stimulation, subgenual cortex (CG25)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Apr 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.
Despite the availability of several treatments, a number of patients with major depression are refractory to therapeutical approaches and therefore suffer from chronic handicap. For these severe patients, neurosurgical therapies can be envisaged. They aim at interrupting bundles that link the orbitofrontal cortex with striatum and can therefore benefit for the patients.
This study intends to repeat Dr. Lozano's study, published in 2005 in the journal Neuron. In this study, they performed a preliminary evaluation of chronic deep brain stimulation (DBS) of the subgenual cingulate region (Brodmann area 25) to treat refractory depression as an alternative to subcaudate tractotomy. This last technique was employed in Grenoble in the 60s with satisfying results before neurosurgery for psychiatric disorders was abandoned. Since 1992, psychosurgical therapies that respect ethical recommendations have regained interest to treat highly impaired patients. Before the investigators can propose deep brain stimulation of subgenual cingulate brain region as a new therapeutic approach for the investigators patients in Grenoble, the investigators decided to reproduce their clinical evaluation on a group of 6 patients, repeating their methodology faithfully. Therefore nothing was changed to the model used by Drs. Lozano and Mayberg and the investigators took advantage of the investigators own expertise regarding deep brain stimulation and subcaudate tractotomy.
Protocol is strictly identical to the one of Mayberg and Lozano in order to confirm their preliminary results. Cartography of physiological consequences of this procedure will be assessed by measuring cerebral blood flow by PET scan (positron emission tomography). Patients will be monitored and thoroughly assessed during including psychiatric, neurological, neurosurgical, neuropsychological and PET scan exams to measure treatment efficacy and potential adverse reactions. Patients will be followed for two more years to assess medium-term complications. This study will be a first step toward further research including potentially a multicentric clinical trial.
Detailed description
The protocol involves assessment of effects of CG25 (subgenual cingulate area-Brodmann 25) DBS on mood, anxiety, apathy, anhedonia, psychomotor retardation, functional state as well as safety and tolerance by specific psychometric scores.
Moreover the protocol aims at highlighting the neurocircuits modulated by CG25 DBS by means of PET (positron emission tomography) imagery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients suffering from severe depression and referred by the psychiatry department of french University Hospital
Key inclusion criteria (9 listed)
- Men and women between 30 and 55 years old
- Women at a reproductive age will have to be under successful contraceptive and will undergo a pregnancy test before inclusion
- Patient suffering from major unipolar depression refractory to conventional therapies
- Chronic depression with ongoing depressive episode > 12 months.
- 4 unsuccessful therapies attempted to treat the ongoing episode, including anti-depressant monotherapies, potentialisation of antidepressant treatments, validated structured psychotherapies, electro-convulsive therapy performed accordingly to ANAES ( Agence Nationale d'Accréditation et d'Evaluation en Santé-the French Health Authority) recommendations (at least 6 sessions with bilateral technique and length control of convulsive crisis).
Key exclusion criteria (9 listed)
- History of cerebral surgery
- Neurological disorder that can interfere with evaluation of surgical procedure or significant cognitive impairment (Mattis score < 30)
- Psychiatric disorder responsible for comorbidity with the major depressive episode (schizophrenia and other delirium, diagnosed anxiety except generalized anxiety disorder, substance dependency)
- Personality disorder of A and B clusters
- Suicidal ideas at evaluation, intention for auto-destruction, repeated suicidal attempts in the last 3 years with emergency care or hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline of the Score at the Hamilton Depression Rating Scale
Time frame: baseline, at 1 year
1 secondary outcome
neurological examination
Time frame: monthly during the first 6 mo and every 3 months until the end of the 1st year
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 11 Oct 2018.
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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.
Stephan Chabardes, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by University Hospital, Grenoble at 1 site 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 9 inclusion and 9 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 11 Oct 2018. 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 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?
Change from Baseline of the Score at the Hamilton Depression Rating Scale (time frame: baseline, at 1 year). 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 11 Oct 2018.