Clinical trial NCT01268137: DBS in Treatment Resistant Major Depression
Official title: DEEP BRAIN STIMULATION IN TREATMENT RESISTANT MAJOR DEPRESSION. Controlled and Crossed Study on Efficacy and Safety.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Resistant Major Depressive Disorder
Keywords: MDD
DBS
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2010-12-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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).

Primary outcomes:
measure: Hamilton Rating Scale for Depression, 17-item version (HRSD-17)
timeFrame: 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
timeFrame: Psychiatric assessments will be performed every two weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Perez Sola Víctor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Molet Joan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.