DBS in Treatment Resistant Major Depression

Phase 3

• Conditions: Resistant Major Depressive Disorder
• Interventions: Procedure: Deep Brain Stimulation

• Registration Number: NCT01268137
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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 Timeline

• Study Start: 2008-01
• Status Verified: 2010-12
• Study First Submitted: 2010-12-28
• Study First Submitted QC: 2010-12-28
• Last Update Submitted: 2010-12-28
• Study First Posted: 2010-12-29
• Last Update Posted: 2010-12-29
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
stimulation on	Deep Brain Stimulation	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
Stimulation off	Deep Brain Stimulation	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

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression, 17-item version (HRSD-17)	Psychiatric assessments will be performed every two weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain