DBS in Treatment Resistant Major Depression

Resistant Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01268137
• Other study ID #: DEP-012004
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 28, 2010
• Last updated: December 28, 2010
• Start date: January 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2010
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Resistant Major Depressive Disorder

Intervention

Procedure:
• Deep Brain Stimulation
Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device

Locations

Country	Name	City	State
Spain	Hospital Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression, 17-item version (HRSD-17)		Psychiatric assessments will be performed every two weeks	No
Secondary	Montgomery-Asberg Depression Rating scale (MADRS) Clinical Global Impression (CGI) of Severity/Improvement Neuropsychological variables		Psychiatric assessments will be performed every two weeks	Yes