DBS in Treatment Resistant Major Depression

• ClinicalTrials.gov Identifier: NCT01268137
• Recruitment Status: Unknown
• First Posted: December 29, 2010
• Last Update Posted: December 29, 2010
• 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

• First Submitted Date: December 28, 2010
• First Posted Date: December 29, 2010
• Last Update Posted Date: December 29, 2010
• Study Start Date: January 2008
• Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 28, 2010): Hamilton Rating Scale for Depression, 17-item version (HRSD-17) [ Time Frame: Psychiatric assessments will be performed every two weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: December 28, 2010): 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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: DBS in Treatment Resistant Major Depression
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Resistant Major Depressive Disorder

Intervention

Procedure: Deep Brain Stimulation

Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device

Study Arms

• 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
  Intervention: Procedure: Deep Brain Stimulation
• 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
  Intervention: Procedure: Deep Brain Stimulation

Publications *

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: December 28, 2010): 8
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: June 2011
• Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Patients of both sexes aged between 18 and 70 years.
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:

1. Female patients who are pregnant or breastfeeding.
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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT01268137
• Other Study ID Numbers: DEP-012004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Original Study Sponsor: Same as current
• Collaborators: 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

• PRS Account: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Verification Date: December 2010