DBS in Treatment Resistant Major Depression

NCT01268137 | Unknown Phase 3

• 1 other identifier: DEP-012004
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Resistant Major Depressive Disorder

Keywords

MDD; DBS

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression, 17-item version (HRSD-17)

  Psychiatric assessments will be performed every two weeks

Secondary Outcomes (1)

• Montgomery-Asberg Depression Rating scale (MADRS) Clinical Global Impression (CGI) of Severity/Improvement Neuropsychological variables

  Psychiatric assessments will be performed every two weeks

Study Arms (2)

stimulation on

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

Procedure: Deep Brain Stimulation

Stimulation off

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

Procedure: Deep Brain Stimulation

Interventions

Deep Brain Stimulation PROCEDURE

Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device

Stimulation off; stimulation on

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Hospital Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (2)

• Puigdemont D, Portella M, Perez-Egea R, Molet J, Gironell A, de Diego-Adelino J, Martin A, Rodriguez R, Alvarez E, Artigas F, Perez V. A randomized double-blind crossover trial of deep brain stimulation of the subcallosal cingulate gyrus in patients with treatment-resistant depression: a pilot study of relapse prevention. J Psychiatry Neurosci. 2015 Jul;40(4):224-31. doi: 10.1503/jpn.130295.

  PMID: 25652752 DERIVED

• Puigdemont D, Perez-Egea R, Portella MJ, Molet J, de Diego-Adelino J, Gironell A, Radua J, Gomez-Anson B, Rodriguez R, Serra M, de Quintana C, Artigas F, Alvarez E, Perez V. Deep brain stimulation of the subcallosal cingulate gyrus: further evidence in treatment-resistant major depression. Int J Neuropsychopharmacol. 2012 Feb;15(1):121-33. doi: 10.1017/S1461145711001088. Epub 2011 Jul 22.

  PMID: 21777510 DERIVED

MeSH Terms

Interventions

Deep Brain Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 29, 2010
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 29, 2010

Record last verified: 2010-12

Locations

ES (1)