DBS in Treatment Resistant Major Depression
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
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
ClinicalTrials.gov Identifier:
NCT01268137
First received: December 28, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Resistant Major Depressive Disorder |
Procedure: Deep Brain Stimulation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | DEEP BRAIN STIMULATION IN TREATMENT RESISTANT MAJOR DEPRESSION. Controlled and Crossed Study on Efficacy and Safety. |
Resource links provided by NLM:
Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Primary Outcome Measures:
- Hamilton Rating Scale for Depression, 17-item version (HRSD-17) [ Time Frame: Psychiatric assessments will be performed every two weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 8 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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
|
Procedure: Deep Brain Stimulation
Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device
|
|
Placebo Comparator: 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
|
Procedure: Deep Brain Stimulation
Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients of both sexes aged between 18 and 70 years.
- 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.
- Patients with a HRSD-17 score of 18 or more.
- Patients with an intellectual capacity that facilitates adequate communication and who are willing to cooperate with all the examinations and protocols of the study.
- Patients who have not modified their antidepressant treatment in the month prior to the study.
- Women of childbearing age using medically approved contraceptive methods.
- Patients who have granted their informed consent in writing.
Exclusion Criteria:
- Female patients who are pregnant or breastfeeding.
- Patients with acute, serious or unstable illnesses.
- Patients experiencing delirium or hallucinations, congruent or otherwise with their mood.
- Patients with a history of substance abuse (other than tobacco or caffeine).
- Patients with concomitant psychiatric disorders from axes I or II of DSM IV-TR.
h)Patients with general contraindications for DBS (pacemaker users, etc).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268137
Locations
| Spain | |
| Hospital Santa Creu i Sant Pau | |
| Barcelona, Spain, 08025 | |
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fondo de Investigacion Sanitaria
Investigators
| Principal Investigator: | Perez Sola Víctor, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Principal Investigator: | Molet Joan, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
More Information
No publications provided
| Responsible Party: | Jordi Virgili, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| ClinicalTrials.gov Identifier: | NCT01268137 History of Changes |
| Other Study ID Numbers: | DEP-012004 |
| Study First Received: | December 28, 2010 |
| Last Updated: | December 28, 2010 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica |
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
|
MDD DBS |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013