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

NCT01778790 | Completed Phase 2 DMC

• 1 other identifier: BSG-13-2319DBS
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Depression Severity rated with Hamilton Depression Rating Scale (HDRS24)

  6 and 12 month after DBS stimulation onset

Other Outcomes (2)

• Comprehensive neuropsychological test battery

  6 and 12 month after DBS stimulation onset

• Adverse Event Schedule

  6 and 12 month after DBS stimulation onset

Study Arms (2)

Sham Stimulation for 8 weeks

SHAM COMPARATOR

Implantation of internal pulse generator (IPG), Sham Stimulation

Device: Deep Brain Stimulation with Activa PC Multi-program Neurostimulator

Stimulation for 8 weeks

ACTIVE COMPARATOR

Implantation of IPG and active stimulation

Device: Deep Brain Stimulation with Activa PC Multi-program Neurostimulator

Interventions

Deep Brain Stimulation with Activa PC Multi-program Neurostimulator DEVICE

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

Sham Stimulation for 8 weeks; Stimulation for 8 weeks

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, 53105, Germany

Location

Related Publications (1)

• Kilian HM, Meyer DM, Bewernick BH, Spanier S, Coenen VA, Schlaepfer TE. Discontinuation of Superolateral Medial Forebrain Bundle Deep Brain Stimulation for Treatment-Resistant Depression Leads to Critical Relapse. Biol Psychiatry. 2019 Mar 15;85(6):e23-e24. doi: 10.1016/j.biopsych.2018.07.025. Epub 2018 Sep 22. No abstract available.

  PMID: 30253883 DERIVED

Related Links

• DBS target site description

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Thomas E. Schlaepfer, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

• Volker Coenen, MD

  University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Psychotherapy

Model Details: Deep Brain Stimulation

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 29, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: January 1, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

DE (1)