Deep Brain Stimulation for Treatment-Refractory Major Depression
Depression
About this trial
This is an interventional treatment trial for Depression focused on measuring Major Depression, Treatment Refractory Major Depression
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Department of Psychiatry and Psychotherapy, University of Bonn
Arms of the Study
Arm 1
Experimental
DBS