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Deep Brain Stimulation in Treatment Resistant Depression

NCT01435148 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2011-09-15

No results posted yet for this study

Summary

Recurrent major depressive disorder affects about 3-5% of the population. It is anticipated that by 2020, depression will be the most common cause of disability worldwide in the 18-55 age group. About two-thirds of these patients respond to first-line treatment (antidepressants). In addition, prolonged administration of antidepressants in patients who respond results in remission in 80% of patients per year. However, a significant proportion of patients either fail to respond in spite of determined pharmacological treatments, electroconvulsive therapy and other treatments or do not achieve sustained remission. The personal, psychiatric, medical, social and economic consequences are devastating for these, treatment resistant, patients. This investigation aims to evaluate the feasibility of deep brain stimulation in patients with treatment resistant depression as a viable alternative to ablative neurosurgery.The hypothesis is that some patients will respond to stimulation in one site rather than the other and that some patients will respond to double rather than single site stimulation.

Conditions

Interventions

PROCEDURE

Deep Brain Stimulation, implanted

Deep brain stimulator implanted during neurosurgery. Specific stimulation parameters programmed after surgery as required. After blinded study arms open stimulation of either or both targets.

Sponsors & Collaborators

  • University of Bristol

    collaborator OTHER

  • North Bristol NHS Trust

    lead OTHER

Principal Investigators

  • Andrea Malizia, MD, PhD · Bristol University

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01435148 on ClinicalTrials.gov