Effects of Deep Brain Stimulation in Treatment Resistant Major Depression

NCT01095263 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-08-06

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

DBS

130Hz, 90us pulsewidth, 4V Amplitude

DEVICE

No Stimulation (Sham)

130Hz, 90us pulsewidth, 0V Amplitude

Sponsors & Collaborators

  • University Hospital, Bonn

    lead OTHER

Principal Investigators

  • Volker Coenen, MD · University Hospital, Bonn

  • Thomas E. Schlaepfer, MD · University Hospital, Bonn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-08-31
Completion
2013-01-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095263 on ClinicalTrials.gov