Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle (slMFB) for the Treatment of Refractory Major Depression

Major Depression Clinical Trial

— FORESEEII  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778790
• Other study ID #: BSG-13-2319DBS
• Status: Completed
• Phase: Phase 2
• Start date: July 2013
• Est. completion date: January 2018

Study information

• Verified date: August 2018
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Device:
• 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

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comprehensive neuropsychological test battery		6 and 12 month after DBS stimulation onset
Other	Adverse Event Schedule	Adverse events will be recorded during the study using a structured questionnaire. All possible adverse events (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. Serious adverse events (SAEs) will be discussed individually if a modification of study protocol is required.; Additional, there will be a safety and efficacy analysis after 6 implanted patients.	6 and 12 month after DBS stimulation onset
Primary	Depression Severity assessed with Montgomery Asberg Depression Scale (MADRS)	Change in MADRS after 6 and 12 months as compared to mean baseline score and one month placebo treatment. 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.	6 and 12 month after DBS stimulation onset
Secondary	Depression Severity rated with Hamilton Depression Rating Scale (HDRS24)	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.	6 and 12 month after DBS stimulation onset

External Links

•   DBS target site description