Effects of Deep Brain Stimulation in Treatment Resistant Major Depression (FORESEE)

August 3, 2018 updated by: Thomas E. Schlaepfer, MD, University Hospital, Bonn

Assessment of Efficacy, Safety and Effects on Quality of Life of Deep Brain Stimulation to the Medial Forebrain Bundle in Patients With Treatment Resistant Major Depression (FORESEE: FOREbrain Stimulation dEprEssion)

The investigators will investigate in a sham controlled design antidepressant effects and safety of DBS to the superolateral branch of the main medial forebrain bundle (slMFB).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The target point for DBS in major depression disorder is located lateral to the ventral tegmental area (VTA) in the midbrain at the branching point of the superolateral branch (slMFB) from the main medial forebrain bundle (MFB).

The exact stimulation coordinates are:

MNI152 coordinates:

left: x(lat.)=-5, y(ap)=-14, z(vert.)=-8 right: x(lat.)=5, y(ap)=-14, z(vert.)=-9

MCP coordinates:

eft: x(lat.)=-6, y(ap)=-1, z(vert.)=-6 right: x(lat.)=4, y(ap)=-1, z(vert.)=-7

All coordinates refer to the MNI152 brain. Legend: slMFB = superolateral branch of medial forebrain bundle, MNI152=Montreal Neurologic Institute brain 152 coordinates, MCP = mid-commissural point coordinates, lat. = lateral, ap= antero-posterior, vert. = vertical.

More information can be found at: http://goo.gl/n9sWV

In addition to the described intervention, we will record EEG activity within the implanted regions during cognitive paradigms (Fell and Axmacher, Nat Rev Neurosci 2011). Specifically, we will investigate the neural mechanisms underlying classification learning, working memory and exploration of rewarded spatial locations and explore oscillatory responses following stimulation of the target regions. These experimental paradigms will be conducted on the first day after electrode implantation.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • University Hospital Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major depression (MD), severe, unipolar type
  • German mother tongue
  • Hamilton Depression Rating Scale (HDRS24) score of > 20
  • Global Assessment of Function (GAF) score of < 45
  • At least 4 episodes of MD or chronic episode > 2 years
  • > 5 years after first episode of MD

  • Failure to respond to

    • adequate trials (>5 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes;
    • adequate trials (>3 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);
    • an adequate trial of electroconvulsive therapy [ECT] (>6 bilateral treatments) and;
    • an adequate trial of individual psychotherapy (>20 sessions with an experienced psychotherapist).
  • Able to give written informed consent
  • No medical comorbidity
  • Drug free or on stable drug regimen at least 6 weeks before study entry

Exclusion Criteria:

  • Current or past nonaffective psychotic disorder
  • Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
  • Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
  • Any surgical contraindications to undergoing DBS
  • Current or unstably remitted substance abuse (aside from nicotine)
  • Pregnancy and women of childbearing age not using effective contraception
  • History of severe personality disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sham then Stimulation
Device: DBS
130Hz, 90us pulsewidth, 4V Amplitude
Other Names:
  • INS
Device: No Stimulation (Sham)
130Hz, 90us pulsewidth, 0V Amplitude
Other Names:
  • INS
Experimental: Stimulation then Sham
Device: DBS
130Hz, 90us pulsewidth, 4V Amplitude
Other Names:
  • INS
Device: No Stimulation (Sham)
130Hz, 90us pulsewidth, 0V Amplitude
Other Names:
  • INS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Severity assessed with Montgomery Asberg Depression Scale (MADRS)
Time Frame: 12 month after DBS stimulation onset

Change in MADRS after 12 months as compared to mean baseline score. MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It is used as an adjunct to the Hamilton Rating Scale for Depression (HAMD) and more sensitive to the changes in depression than the Hamilton Scale is.

MADRS will be rated 3 times for baseline assessment, weekly during parameter optimization and monthly during follow-up. Reduction compared to baseline will be assessed after 12 months of DBS.
12 month after DBS stimulation onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Severity rated with Hamilton Depression Rating Scale (HDRS24)
Time Frame: 12 month after DBS stimulation onset

The Hamilton Rating Scale for Depression (HRSD), also known as the Hamilton Depression Rating Scale (HDRS) or abbreviated to HAM-D, is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. The questionnaire rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. The questionnaire is presently one of the most commonly used scales for rating depression in medical research.

Measures will be taken at same time points as primary outcome measure.
12 month after DBS stimulation onset
Adverse Event Schedule
Time Frame: 12 month after DBS stimulation onset
Adverse events will be recorded during the study using a structured questionnaire. All possible AEs are assessed in severity, duration and actions taken. 12 months after stimulation onset results will be compiled and rated as being due to the surgical procedure, device, or stimulation. SAEs will be discussed individually if a modification of study protocol is required.
12 month after DBS stimulation onset
Comprehensive neuropsychological test battery
Time Frame: 12 month after DBS stimulation onset
12 month after DBS stimulation onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: Volker Coenen, MD, University Hospital, Bonn
  • Principal Investigator: Thomas E. Schlaepfer, MD, University Hospital, Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Actual)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSG-10-4711DBS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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