DBS in Treatment Resistant Major Depression

Study Overview
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Brief Summary
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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
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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

Official Title
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DEEP BRAIN STIMULATION IN TREATMENT RESISTANT MAJOR DEPRESSION. Controlled and Crossed Study on Efficacy and Safety.

Conditions
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Resistant Major Depressive Disorder

Intervention / Treatment
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* Procedure: Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stimulation on<br>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<br>* Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device<br>|
| Placebo Comparator: Stimulation off<br>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<br>* Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression, 17-item version (HRSD-17) |  | Psychiatric assessments will be performed every two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating scale (MADRS) Clinical Global Impression (CGI) of Severity/Improvement Neuropsychological variables |  | Psychiatric assessments will be performed every two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDD, DBS