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Major Depressive DisorderPhase 1/2DBSTRDNCT01921543

Deep Brain Stimulation in Treatment Refractory Depression

A Phase 1/2 study testing ITP Stimulation, CI/BNST stimulation and No stimulation in people with Major Depressive Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
ITP Stimulation, CI/BNST stimulation and No stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteBelgium
Study dates
Jan 2005to Oct 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

About this study

Official title: Electrical Stimulation of the Internal Capsule/Grey Matter and Inferior Thalamic Peduncle for Treatment-refractory Major Depressive Disorder

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)

Read the 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.

Being tested
ITP Stimulation, CI/BNST stimulation, No stimulation
Keywords
Deep Brain Stimulation, Major Depressive Disorder, Psychosurgery, Electrical stimulation
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ITP StimulationDevice

    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 stimulationDevice

    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 stimulationDevice

Study groups in NCT01921543
Study groupRoleWhat they receive
CI/BNST stimulation onExperimentalNot described
Receives: Device: CI/BNST stimulation
CI/BNST vs stimulation offExperimentalrandomized, double blind, 1 week crossover
Receives: Device: CI/BNST stimulation; Device: No stimulation
ITP stimulation onExperimentalNot described
Receives: Device: ITP Stimulation
CI/BNST vs ITP vs stimulation offExperimentalrandomized, double blind, two month crossover
Receives: Device: ITP Stimulation; Device: CI/BNST stimulation; Device: No stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale

    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.

    Measured: up to 14 months

Secondary outcomes (10)

  1. Montgomery- Asberg Depression Rating Scale (MADRS)

    Measured: up to 14 months

  2. Inventory for Depressive Symptoms, Self-Report (IDS-SR)

    Measured: 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)

    Measured: up to 14 months

  4. Global Assessment of Function (GAF)

    Measured: up to 14 months

  5. patient-rated Symptom CheckList (SCL-90)

    Measured: 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

    Measured: up to 14 months

  7. Hopelessness: using the Beck Hopelessness scale

    Measured: up to 14 months

  8. Hamilton Anxiety Rating Scale (HARS)

    Measured: up to 14 months

  9. Young Mania Rating Scale (YMRS)

    Measured: up to 14 months

  10. Side Effects Questionnaire (SEQ)

    Measured: up to 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2013 (estimated)
  2. Study startJan 2005
  3. Primary completionOct 2013
  4. Study completionOct 2013

Why it stopped: Patient inclusion was very tedious and slower than expected. (7 patients in 5 years)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01921543
Sponsor's protocol ID
s28650
Acronym
DBSTRD
Status last verified
Jun 2013
First submitted
8 Jan 2013
Last updated
16 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ITP Stimulation, CI/BNST stimulation and No stimulation in people with Major Depressive Disorder, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Patient inclusion was very tedious and slower than expected. (7 patients in 5 years)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (time frame: up to 14 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01921543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.

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