Status:
COMPLETED
Deep Brain Stimulation for Treatment-Refractory Major Depression
Lead Sponsor:
University Hospital, Bonn
Collaborating Sponsors:
Medtronic
Conditions:
Depression
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
Brief Summary
This study will investigate the use of deep brain stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-refractory major depression.
Detailed Description
Despite advances in pharmacotherapy and psychotherapy for major depression, a substantial number of patients fail to improve significantly even after years of conventional and experimental interventio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00122031
Start Date
July 1 2005
End Date
January 1 2011
Last Update
June 14 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Psychiatry and Psychotherapy, University of Bonn
Bonn, Germany, 53105