Status:
UNKNOWN
Deep Brain Stimulation in Treatment Resistant Depression
Lead Sponsor:
North Bristol NHS Trust
Collaborating Sponsors:
University of Bristol
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Patients will be selected according to inclusion/ exclusion criteria after referral from their psychiatric team or, in exceptional cases, from their GP. Patients will be referred to the trial after be...
Eligibility Criteria
Inclusion
- Patients who have major depressive disorder (according to the Diagnostic and Statistical Manual version IV) and who:
- Do not respond or have ceased to respond to treatment including:
- Cognitive Behaviour Therapy (CBT) or other validated psychotherapy.
- Antidepressants from three different classes in BNF or maximum tolerated (if lower than BNF) doses
- Lithium augmentation
- 2 courses of ECT (or only respond to "maintenance" ECT)(lack of response in previous episodes and unwillingness to try again will also count).
- Consent to take part in the trial
- Are physically fit
- Have no suicidal intent
- Have no history of hypomania, mania or psychosis
- Montgomery Asberg Depression Rating Scale score \> 21
Exclusion
- Patients with a history of continuous depression from late teens or early twenties without clear response to treatments or without periods of spontaneous remission,
- Pregnancy
- History of significant head trauma
- Dementia
- Cerebral infarcts
- Poor physical health
- No capacity to consent
- Inability to carry out research protocol
- Mood incongruent psychotic phenomena or drug or alcohol addiction. In addition patients will be excluded if detained under the Mental Health Act.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01435148
Start Date
December 1 2006
End Date
December 1 2012
Last Update
September 15 2011
Active Locations (1)
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1
Neurosurgey Department, Frenchay Hospital
Bristol, Bristol, United Kingdom, BS16 1LE