Overview

This trial is active, not recruiting.

Condition resistant major depressive disorder
Treatment deep brain stimulation
Phase phase 3
Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborator Fondo de Investigacion Sanitaria
Start date January 2008
End date June 2011
Trial size 8 participants
Trial identifier NCT01268137, DEP-012004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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
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)
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
deep brain stimulation
Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device

Primary Outcomes

Measure
Hamilton Rating Scale for Depression, 17-item version (HRSD-17)
time frame: Psychiatric assessments will be performed every two weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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).

Additional Information

Official title DEEP BRAIN STIMULATION IN TREATMENT RESISTANT MAJOR DEPRESSION. Controlled and Crossed Study on Efficacy and Safety.
Principal investigator Perez Sola Víctor, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.