Deep Brain Stimulation in Treatment Refractory Depression

NCT ID: NCT01921543

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2013-10-31

Brief Summary

The main aim of this trial was to investigate whether patients suffering from treatment refractory- Major Depressive Disorder (MDD) can benefit from DBS (Deep Brain Stimulation) in the brain areas known as inferior thalamic peduncle (ITP) and/or Capsula Interna/Bed nucleus of the stria terminalis (CI/BNST)

Detailed Description

This study aims to investigate the effect of deep brain stimulation (DBS)in major depressive disorder (MDD). After implantation of the DBS system, the effects of deep brain stimulation in ITP and CI/BNST will be evaluated.

The design of the study consists of two consecutive crossover phases, interspaced with 2 optimalisation episodes. After a period of optimalisation of CI/BNST stimulation parameters, patients will be randomised in two groups. Half of the group of patients will receive stimulation in CI/BNST. The other half will not. After one week both groups will switch conditions during a period of one week. This will give an idea of the effects of stimulation in CI/BNST on the outcome measures. Outcome measures will be evaluated after each week.

After this first crossover patients will continue to an optimalisation phase of ITP stimulation parameters. A second crossover will then follow. The effects of ITP stimulation, CI/BNST stimulation and no stimulation will be compared. In this phase patients will again be randomised to receive one of the six possible combinations of three consecutive periods of two months for the three different stimulation conditions (ITP stimulation, CI/BNST stimulation and no stimulation).

Evaluations of outcome measures will be performed by blinded evaluators. This design will limit the duration of periods in which these severly ill patients are not stimulated.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CI/BNST stimulation on

Group Type: EXPERIMENTAL

CI/BNST stimulation

Intervention Type: DEVICE

Model 7428 Kinetra® Neurostimulator

Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead

Model 3387 DBSTM Brain Lead

Model 7482-51 Extension

Model 7482-66 Extension

Model 7482-95 Extension

Model 7436 AccessTM Therapy Controller

Model 3628 Dual Screener TM

Model 8840 N'Vision

CI/BNST vs stimulation off

randomized, double blind, 1 week crossover

Group Type: EXPERIMENTAL

CI/BNST stimulation

Intervention Type: DEVICE

Model 7428 Kinetra® Neurostimulator

Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead

Model 3387 DBSTM Brain Lead

Model 7482-51 Extension

Model 7482-66 Extension

Model 7482-95 Extension

Model 7436 AccessTM Therapy Controller

Model 3628 Dual Screener TM

Model 8840 N'Vision

No stimulation

Intervention Type: DEVICE

ITP stimulation on

Group Type: EXPERIMENTAL

ITP Stimulation

Intervention Type: DEVICE

Model 7428 Kinetra® Neurostimulator

Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead

Model 3387 DBSTM Brain Lead

Model 7482-51 Extension

Model 7482-66 Extension

Model 7482-95 Extension

Model 7436 AccessTM Therapy Controller

Model 3628 Dual Screener TM

Model 8840 N'Vision

CI/BNST vs ITP vs stimulation off

randomized, double blind, two month crossover

Group Type: EXPERIMENTAL

ITP Stimulation

Intervention Type: DEVICE

Model 7428 Kinetra® Neurostimulator

Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead

Model 3387 DBSTM Brain Lead

Model 7482-51 Extension

Model 7482-66 Extension

Model 7482-95 Extension

Model 7436 AccessTM Therapy Controller

Model 3628 Dual Screener TM

Model 8840 N'Vision

CI/BNST stimulation

Intervention Type: DEVICE

Model 7428 Kinetra® Neurostimulator

Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead

Model 3387 DBSTM Brain Lead

Model 7482-51 Extension

Model 7482-66 Extension

Model 7482-95 Extension

Model 7436 AccessTM Therapy Controller

Model 3628 Dual Screener TM

Model 8840 N'Vision

No stimulation

Intervention Type: DEVICE

Interventions

ITP Stimulation

Model 7428 Kinetra® Neurostimulator

Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead

Model 3387 DBSTM Brain Lead

Model 7482-51 Extension

Model 7482-66 Extension

Model 7482-95 Extension

Model 7436 AccessTM Therapy Controller

Model 3628 Dual Screener TM

Model 8840 N'Vision

Intervention Type: DEVICE

CI/BNST stimulation

Model 7428 Kinetra® Neurostimulator

Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead

Model 3387 DBSTM Brain Lead

Model 7482-51 Extension

Model 7482-66 Extension

Model 7482-95 Extension

Model 7436 AccessTM Therapy Controller

Model 3628 Dual Screener TM

Model 8840 N'Vision

Intervention Type: DEVICE

No stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Major depressive disorder, severe, unipolar type, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity.
• 17-item Hamilton Depression Rating Scale (HDRS) score of at least 19.
• Global Assessment of Function (GAF) score of 45 or less.
• A recurrent (>4 episodes) or chronic (episode duration >2 years) course and a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal ideation or a history of previous suicide attempts or other self-injurious behavior).
• Failure to respond to:

• adequate trials (>6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes AND;
• adequate trials (>4 weeks at the usually recommended or maximum tolerated dose) of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) AND;
• an adequate trial of Electroconvulsiontherapy (ECT) (>6 bilateral treatments) AND;
• adequate relapse prevention by antidepressant medication or maintenance ECT or an adequate trial of individual psychotherapy.
• Age ≥18 - ≤65 years.
• Able to comply with the operational and administrative requirements of participation in the study ; able to comply with the questionnaires and the protocol.
• Able to give written informed consent.
• Either drug-free or on a stable drug regimen for at least 6 weeks at the time of entry into the study.
• Good general health.
• Candidates may have undertaken additional trials of potentially beneficial novel combinations of medication and psychotherapy, or they may have undertaken trials of novel interventions lacking definitive evidence of efficacy in severe depression (e.g., light therapy, herbal therapy, transcranial magnetic stimulation, vagal nerve stimulation).

Exclusion Criteria

• Current or past non-affective psychotic disorder.
• Any current clinically significant neurological disorder or medical illness affecting brain function.
• Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
• Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation or significant cardiac or other medical risk factors for surgery.
• Current or unstably remitted substance abuse.
• Pregnancy and women of childbearing age not using effective contraception.
• History of severe personality disorder, especially cluster B.
• Imminent risk of suicide (based on the judgment of the investigators)
• Present participation in another clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

s28650

Identifier Type: -

Identifier Source: org_study_id