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DBS in Treatment Resistant Major Depression

Primary Purpose

Resistant Major Depressive Disorder

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resistant Major Depressive Disorder focused on measuring MDD, DBS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

stimulation on

Stimulation off

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression, 17-item version (HRSD-17)

Secondary Outcome Measures

Montgomery-Asberg Depression Rating scale (MADRS) Clinical Global Impression (CGI) of Severity/Improvement Neuropsychological variables

Full Information

First Posted
December 28, 2010
Last Updated
December 28, 2010
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Fondo de Investigacion Sanitaria
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1. Study Identification

Unique Protocol Identification Number
NCT01268137
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Fondo de Investigacion Sanitaria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Major Depressive Disorder
Keywords
MDD, DBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stimulation on
Arm Type
Active Comparator
Arm Description
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
Arm Title
Stimulation off
Arm Type
Placebo Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression, 17-item version (HRSD-17)
Time Frame
Psychiatric assessments will be performed every two weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perez Sola Víctor, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Molet Joan, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25652752
Citation
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.
Results Reference
derived
PubMed Identifier
21777510
Citation
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.
Results Reference
derived

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DBS in Treatment Resistant Major Depression

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