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Deep Brain Stimulation in Treatment Refractory Depression (DBSTRD)

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ClinicalTrials.gov Identifier: NCT01921543
Recruitment Status : Terminated (Patient inclusion was very tedious and slower than expected. (7 patients in 5 years))
First Posted : August 13, 2013
Last Update Posted : July 16, 2015
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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)

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: ITP Stimulation Device: CI/BNST stimulation Device: No stimulation Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electrical Stimulation of the Internal Capsule/Grey Matter and Inferior Thalamic Peduncle for Treatment-refractory Major Depressive Disorder
Study Start Date : January 2005
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CI/BNST stimulation on 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


Experimental: CI/BNST vs stimulation off
randomized, double blind, 1 week crossover
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


Device: No stimulation
Experimental: ITP stimulation on Device: 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


Experimental: CI/BNST vs ITP vs stimulation off
randomized, double blind, two month crossover
Device: 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


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


Device: No stimulation



Primary Outcome Measures :
  1. Change from baseline in depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale [ Time Frame: up to 14 months ]
    The time frame is an approximation as evaluation is performed after each crossover phase. The time interval between baseline and evaluation depends on the time required for optimisation of DBS parameters.


Secondary Outcome Measures :
  1. Montgomery- Asberg Depression Rating Scale (MADRS) [ Time Frame: up to 14 months ]
  2. Inventory for Depressive Symptoms, Self-Report (IDS-SR) [ Time Frame: up to 14 months ]
  3. Global measures of illness severity and improvement:the clinician-rated Clinical Global Impressions - Severity (CGI-S) and Clinical Global Impressions - Improvement (CGI-I) scales, and the patient-rated Patient Global Impressions (PGI-S and PGI-I) [ Time Frame: up to 14 months ]
  4. Global Assessment of Function (GAF) [ Time Frame: up to 14 months ]
  5. patient-rated Symptom CheckList (SCL-90) [ Time Frame: up to 14 months ]
  6. Cognitive function: Rey Auditory Verbal Learning Test; Trailmaking A & B, Stroop Test, Rey-Osterrieth complex figure test ; Wisconsin Card Sorting Test; Standard Progressive Matrices of Raven; Digit Span Test; Word Fluency Test [ Time Frame: up to 14 months ]
  7. Hopelessness: using the Beck Hopelessness scale [ Time Frame: up to 14 months ]
  8. Hamilton Anxiety Rating Scale (HARS) [ Time Frame: up to 14 months ]
  9. Young Mania Rating Scale (YMRS) [ Time Frame: up to 14 months ]
  10. Side Effects Questionnaire (SEQ) [ Time Frame: up to 14 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921543


Locations
Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Medtronic

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01921543     History of Changes
Other Study ID Numbers: s28650
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: June 2013

Keywords provided by Universitaire Ziekenhuizen Leuven:
Deep Brain Stimulation
Major Depressive Disorder
Psychosurgery
Electrical stimulation

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms