Overview

This trial is active, not recruiting.

Condition major depression
Treatment deep brain stimulation with activa pc multi-program neurostimulator
Phase phase 2
Sponsor University Hospital, Bonn
Start date August 2013
End date March 2015
Trial size 12 participants
Trial identifier NCT01778790, BSG-13-2319DBS

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Sham Comparator)
Implantation of internal pulse generator (IPG), Sham Stimulation
deep brain stimulation with activa pc multi-program neurostimulator
Device: DBS 130 Hertz (Hz) frequency, 90us pulsewidth, 4 Volt (V) currency Amplitude Device: DBS - No Stimulation (Sham) 130 Hertz (Hz)frequency, 90us pulsewidth, 0 Volt (V) currency Amplitude
(Active Comparator)
Implantation of IPG and active stimulation
deep brain stimulation with activa pc multi-program neurostimulator
Device: DBS 130 Hertz (Hz) frequency, 90us pulsewidth, 4 Volt (V) currency Amplitude Device: DBS - No Stimulation (Sham) 130 Hertz (Hz)frequency, 90us pulsewidth, 0 Volt (V) currency Amplitude

Primary Outcomes

Measure
Depression Severity assessed with Montgomery Asberg Depression Scale (MADRS)
time frame: 6 and 12 month after DBS stimulation onset

Secondary Outcomes

Measure
Depression Severity rated with Hamilton Depression Rating Scale (HDRS24)
time frame: 6 and 12 month after DBS stimulation onset

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

Inclusion Criteria: - Major depression (MD), severe, unipolar - German mother tongue - Age 20 to 75 Years - Hamilton Depression Rating Scale (HRSD24) score of > 21 - Global Assessment of Function (GAF) score of < 45 - At least 4 episodes of depression or chronic episode > 2 years - 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 - Compliance to participate in the study - Drug free or on stable drug regimen at least 6 weeks before study entry Exclusion Criteria: - Current or past non-affective 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 - Acute suicidal tendency

Additional Information

Official title 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 II: FOREbrain Stimulation dEprEssion)
Principal investigator Thomas E. Schlaepfer, MD
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: Montreal Neurologic Institute brain 152 coordinates (MNI152 coordinates): left: x(lat.)=-5, y(ap)=-14, z(vert.)=-8 right: x(lat.)=5, y(ap)=-14, z(vert.)=-9 Mid-commissural point coordinates (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 lat. = lateral, ap= anteroposterior, vert. = vertical. More information can be found at: http://goo.gl/n9sWV
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by University Hospital, Bonn.