Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder

NCT01476527 | Completed

• 1 other identifier: 10-0696-A
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Bipolar Disorder (BD) is among the most comon and challenging conditions in psychiatry. Although episodes of mania and hypomania define the different types of the disorder, the clinical picture is one dominated by depressed mood and agitation. The mainstay of BD treatment has thus far been pharmacologic, but many patients remain severely disabled by their condition, despite the best available medical treatment. The successful use of deep brain stimulation (DBS) in movement disorders, and its promising results in major depressive disorder (MDD), has led researchers to consider its use in highly selected refractory cases of BD. Evidence form the imaging and circuitry literature suggests that similar underlying dyfunctional anatomic structures subserve both MDD and BD, indicating that modulation of key structures, can lead to an amelioration of symptoms and mood stabilization. Here, we propose a phase I clinical trial to evaluate the safety of DBS in BD.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression

  Hamilton Depression Rating Scale (HAMD), Montgomery-Åsberg Depression Rating Scale (MADRS)

  Change from baseline in depression scores at 3 months, 6 months and 12 months

Secondary Outcomes (2)

• Young Mania Rating Scale

  Change from baseline in manic, hypomanic scores at 3 months, 6 months and 12 months

• Questionnaires-Quality of Life

  Change from baseline in quality of life scores at 3 months, 6 months and 12 months

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone

Procedure: Deep Brain Stimulation

Interventions

Deep Brain Stimulation PROCEDURE

Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone

Deep Brain Stimulation

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female patients between the age of 30-60
• DSM IV-TR diagnosis of Bipolar Disorder I or II
• Diagnosis for \>12 months with a HRSD-17 score of at least 20
• Failure of medical therapy, defined as follows:
• a. Failure of a minimum of two (2) first line as well as two (2) second line treatments for bipolar mania and depression
• No neurological disease
• No other active Axis I or Axis II co-morbidity that is the focus of clinical attention, as defined by the Mini International Neuropsychiatric Interview (MINI)
• No substance abuse or substance use disorder for minimum of three months prior to study
• Able to give informed consent
• Able to comply with all testing and follow-up visit requirements defined by the Study Protocol
• Mini mental status examination (MMSE) score \>25
• Pre-menopausal women must agree to use acceptable methods of birth control (radiation risk of PET)

You may not qualify if:

• History of psychosis, or psychotic episodes
• Alcohol or substance dependence or abuse within 6 months, excluding nicotine or caffeine.
• Current suicidal ideation, plan or intent for self-harm.
• A suicide attempt in the past 1 year
• Major medical illness, cardiac pacemaker/defibrillator, and other implanted stimulator
• Likely to relocate or move to a location distant from the study site within one year of enrollment
• Any contraindication to MRI or PET scanning

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Andres M Lozano, MD PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Roger McIntyre, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Professor of Surgery

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 22, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

CA (1)