Deep Brain Stimulation for Treatment-Refractory Major Depression

Phase 1

Completed

• Conditions: Depression
• Interventions: Device: Deep Brain Stimulation with Medtronic Activa Neurostimulator

• Registration Number: NCT00122031
• Lead Sponsor: University Hospital, Bonn

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 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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-15
• Study First Submitted QC: 2005-07-15
• Study First Posted: 2005-07-21
• Primary Completion: 2009-04
• Study Completion: 2011-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DBS	Deep Brain Stimulation with Medtronic Activa Neurostimulator	-

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HDRS)	analyzed at 12 and 24 month after stimulation onset

Secondary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	analyzed at 12 and 24 month after stimulation onset

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, University of Bonn; 🇩🇪 Bonn, Germany