Deep Brain Stimulation for Treatment-Refractory Major Depression

University Hospital Bonn (UKB)

Status and phase

Completed

Phase 1

Conditions

Depression

Treatments

Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00122031

BSG-04-006

Details and patient eligibility

About

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.

Full 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 interventions. Bilateral deep brain stimulation (DBS) to the region of the anterior capsule/ventral striatum is an adjustable and reversible procedure that may be a more effective treatment for patients with major depression. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory major depression.

Enrollment

13 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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