NCT01095263

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

March 24, 2010

Last Update Submit

August 3, 2018

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

  • Depression Severity assessed with Montgomery Asberg Depression Scale (MADRS)

    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 Outcomes (3)

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

    12 month after DBS stimulation onset

  • Adverse Event Schedule

    12 month after DBS stimulation onset

  • Comprehensive neuropsychological test battery

    12 month after DBS stimulation onset

Study Arms (2)

Sham then Stimulation

EXPERIMENTAL
Device: DBSDevice: No Stimulation (Sham)

Stimulation then Sham

EXPERIMENTAL
Device: DBSDevice: No Stimulation (Sham)

Interventions

DBSDEVICE

130Hz, 90us pulsewidth, 4V Amplitude

Also known as: INS
Sham then StimulationStimulation then Sham
No Stimulation (Sham)DEVICE

130Hz, 90us pulsewidth, 0V Amplitude

Also known as: INS
Sham then StimulationStimulation then Sham

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, 53105, Germany

Location

Related Publications (5)

  • Coenen VA, Schlaepfer TE, Allert N, Madler B. Diffusion tensor imaging and neuromodulation: DTI as key technology for deep brain stimulation. Int Rev Neurobiol. 2012;107:207-34. doi: 10.1016/B978-0-12-404706-8.00011-5.

    PMID: 23206684BACKGROUND

  • Coenen VA, Schlaepfer TE, Maedler B, Panksepp J. Cross-species affective functions of the medial forebrain bundle-implications for the treatment of affective pain and depression in humans. Neurosci Biobehav Rev. 2011 Oct;35(9):1971-81. doi: 10.1016/j.neubiorev.2010.12.009. Epub 2010 Dec 22.

    PMID: 21184778BACKGROUND

  • Schlaepfer TE, Bewernick BH, Kayser S, Madler B, Coenen VA. Rapid effects of deep brain stimulation for treatment-resistant major depression. Biol Psychiatry. 2013 Jun 15;73(12):1204-12. doi: 10.1016/j.biopsych.2013.01.034. Epub 2013 Apr 3.

    PMID: 23562618RESULT

  • Coenen VA, Madler B, Schlaepfer TE. Reply to: medial forebrain bundle stimulation-speed access to an old or entry into a new depression neurocircuit? Biol Psychiatry. 2013 Dec 15;74(12):e45-6. doi: 10.1016/j.biopsych.2013.06.017. Epub 2013 Aug 2. No abstract available.

    PMID: 23916389RESULT

  • 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: 30253883DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Volker Coenen, MD

    University Hospital, Bonn

    PRINCIPAL INVESTIGATOR

  • Thomas E. Schlaepfer, MD

    University Hospital, Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Psychotherapy

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 30, 2010

Study Start

April 1, 2011

Primary Completion

August 1, 2012

Study Completion

January 1, 2013

Last Updated

August 6, 2018

Record last verified: 2018-08

Locations

DE(1)