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
Sponsor:
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
  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.

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:

  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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 18, 2014