Deep Brain Stimulation in Treatment Resistant Depression

NCT01435148 | Unknown DMC

• 2 other identifiers: 175906/Q2001/189
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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

Treatment Resistant Depression

Keywords

Deep Brain Stimulation; Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Decrease in Montgomery and Asberg Rating Scale score of at least 50% at an average of 18 months after implantation.

  MADRS is a standard depression rating scale for major depressive disorder over time

  End of contact selection and adjustment plus 6 months. An average of 18 months after implantation.

Secondary Outcomes (3)

• Clinical Global Impression Improvement Scale(CGI-I). Score <4.

  End of contact selection and adjustment plus 6 months. An average of 18 months after implantation

• Global Assessment of Functioning scale, an improvement of >1/2(100-initial score)

  End of contact selection and adjustment plus 6 months. An average of 18 months after implantation

• A decrease of 50% in Hamilton Depression Rating Scale (17 items) at End of contact selection and adjustment plus 6 months. An average of 18 months after implantation

  End of contact selection and adjustment plus 6 months. An average of 18 months after implantation

Study Arms (2)

Stimulation of SGC then VACNAC targets

EXPERIMENTAL

Stimulation of the subgenual cingulate cortex (SGC) target will take place first, followed by stimulation of the ventral anterior capsule nucleus accumbens target (VACNAC) if no clinical response after a minimum of 4 months.

Procedure: Deep Brain Stimulation, implanted

Stimulation of VACNAC then SGC targets.

EXPERIMENTAL

Stimulation of the ventral anterior capsule nucleus accumbens target (VACNAC) will take place first, followed by stimulation of the subgenual cingulate cortex target (SGC) if no clinical response after a minimum of 4 months.

Procedure: Deep Brain Stimulation, implanted

Interventions

Deep Brain Stimulation, implanted PROCEDURE

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.

Stimulation of SGC then VACNAC targets; Stimulation of VACNAC then SGC targets.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Bristol NHS Trust: lead
• University of Bristol: collaborator

Study Sites (1)

Neurosurgey Department, Frenchay Hospital

Bristol, Bristol, BS16 1LE, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Deep Brain Stimulation; Drug Implants

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Andrea Malizia, MD, PhD

  Bristol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Andrea Malizia

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 15, 2011
• Study Start: December 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 15, 2011

Record last verified: 2011-09

Locations

GB (1)