DBS in Treatment Resistant Major Depression
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ClinicalTrials.gov Identifier: NCT01268137 |
Recruitment Status : Unknown
Verified December 2010 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was: Active, not recruiting
First Posted : December 29, 2010
Last Update Posted : December 29, 2010
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Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Tracking Information | |||||||
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First Submitted Date ICMJE | December 28, 2010 | ||||||
First Posted Date ICMJE | December 29, 2010 | ||||||
Last Update Posted Date | December 29, 2010 | ||||||
Study Start Date ICMJE | January 2008 | ||||||
Estimated Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Hamilton Rating Scale for Depression, 17-item version (HRSD-17) [ Time Frame: Psychiatric assessments will be performed every two weeks ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE |
Montgomery-Asberg Depression Rating scale (MADRS) Clinical Global Impression (CGI) of Severity/Improvement Neuropsychological variables [ Time Frame: Psychiatric assessments will be performed every two weeks ] | ||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | DBS in Treatment Resistant Major Depression | ||||||
Official Title ICMJE | DEEP BRAIN STIMULATION IN TREATMENT RESISTANT MAJOR DEPRESSION. Controlled and Crossed Study on Efficacy and Safety. | ||||||
Brief Summary | This study aims at assessing efficacy and safety of DBS for treatment of patients suffering from resistant major depression, by means of a random, controlled and crossed study. | ||||||
Detailed Description | The first phase of the study will consist of implanting electrodes and applying continuous stimulation until the patients stabilise clinically. This period is anticipated between 6 and 9 months. The next phase will consist of the crossover study. Responders will be randomised to either of 2 groups for a period of 3 months: a stimulation-on group and a stimulation-off group. Patients will then be crossed over to the other group for a further 3 months. Fortnightly visits will be made during the entire study to evaluate treatment efficacy and patient tolerance | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Resistant Major Depressive Disorder | ||||||
Intervention ICMJE | Procedure: Deep Brain Stimulation
Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Actual Enrollment ICMJE |
8 | ||||||
Original Actual Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | June 2011 | ||||||
Estimated Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
h)Patients with general contraindications for DBS (pacemaker users, etc). |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Spain | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01268137 | ||||||
Other Study ID Numbers ICMJE | DEP-012004 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Jordi Virgili, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Fondo de Investigacion Sanitaria | ||||||
Investigators ICMJE |
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PRS Account | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||||||
Verification Date | December 2010 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |