Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
8 participants
INTERVENTIONAL
2008-01-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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stimulation on
At first stage, electrodes will be implanted in all patients, who will be continuously stimulated for several months. After this stage, the random-crossed part of the study will start, and patients who responded to DBS will be randomly distributed in two groups: on stimulation or off stimulation group, for the next three months. Subsequently, patients will be allocated in the other group (on or off, crossed part) for three months
Deep Brain Stimulation
Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device
Stimulation off
At first stage, electrodes will be implanted in all patients, who will be continuously stimulated for several months. After this stage, the random-crossed part of the study will start, and patients who responded to DBS will be randomly distributed in two groups: on stimulation or off stimulation group, for the next three months. Subsequently, patients will be allocated in the other group (on or off, crossed part) for three months
Deep Brain Stimulation
Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device
Interventions
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Deep Brain Stimulation
Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device
Eligibility Criteria
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Inclusion Criteria
2. Patients diagnosed as having an MDD episode according to DSM-IV-TR criteria, resistant to pharmacological treatment with a score of 4 in the Thase-Rush index, with ECT contraindicated or having failed to produce a maintained response.
3. Patients with a HRSD-17 score of 18 or more.
4. Patients with an intellectual capacity that facilitates adequate communication and who are willing to cooperate with all the examinations and protocols of the study.
5. Patients who have not modified their antidepressant treatment in the month prior to the study.
6. Women of childbearing age using medically approved contraceptive methods.
7. Patients who have granted their informed consent in writing.
Exclusion Criteria
2. Patients with acute, serious or unstable illnesses.
3. Patients experiencing delirium or hallucinations, congruent or otherwise with their mood.
4. Patients with a history of substance abuse (other than tobacco or caffeine).
5. Patients with concomitant psychiatric disorders from axes I or II of DSM IV-TR.
h)Patients with general contraindications for DBS (pacemaker users, etc).
18 Years
70 Years
ALL
No
Sponsors
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Fondo de Investigacion Sanitaria
OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigators
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Perez Sola Víctor, MD
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Molet Joan, MD
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Locations
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Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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References
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Puigdemont D, Portella M, Perez-Egea R, Molet J, Gironell A, de Diego-Adelino J, Martin A, Rodriguez R, Alvarez E, Artigas F, Perez V. A randomized double-blind crossover trial of deep brain stimulation of the subcallosal cingulate gyrus in patients with treatment-resistant depression: a pilot study of relapse prevention. J Psychiatry Neurosci. 2015 Jul;40(4):224-31. doi: 10.1503/jpn.130295.
Puigdemont D, Perez-Egea R, Portella MJ, Molet J, de Diego-Adelino J, Gironell A, Radua J, Gomez-Anson B, Rodriguez R, Serra M, de Quintana C, Artigas F, Alvarez E, Perez V. Deep brain stimulation of the subcallosal cingulate gyrus: further evidence in treatment-resistant major depression. Int J Neuropsychopharmacol. 2012 Feb;15(1):121-33. doi: 10.1017/S1461145711001088. Epub 2011 Jul 22.
Other Identifiers
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DEP-012004
Identifier Type: -
Identifier Source: org_study_id