Bipolar DisorderNCT01476527
Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder
A study testing Deep Brain Stimulation in people with Bipolar Disorder, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder: Pilot Trial
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.
Read the detailed description
Bipolar disorder (BD) is a complex and disabling disorder that is among the most challenging diagnoses 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. Detection and diagnosis of BD remains a challenge, as most individuals with BD spend many years misdiagnosed as major depression disorder (MDD), often leading to under-treatment or inappropriate treatment. Several studies have attempted to elucidate features of a major depressive episode that indicate an underlying diagnosis of MDD versus bipolar depression.
During the last fifteen years, there have been significant advances in our understanding of the pathophysiology and relevant neuroanatomy and neurocircuitry underlying mood disorders. Much of that progress has been made as a result of technological advances in neuroimaging, both structural and functional.
Deep Brain Stimulation is a neurosurgical tool has been used for over twenty-five years to treat various neurologic and psychiatric conditions. DBS is believed to work by using small amounts of electricity to disrupt the activity of brain structures that produce troublesome symptoms. In the case of Parkinson's disease, DBS is successful in treating the tremor and general slowing that are major parts of that condition. DBS has also been used in psychiatric patients, both as part of treatment, in cases of Obsessive-Compulsive Disorder (OCD), and research, in cases of Depression. 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 dysfunctional anatomic structures subserve both MDD and BD, indicating that modulation of key structures, can lead to an amelioration of symptoms and mood stabilization.
Our primary objective is to establish the safety of deep brain stimulation in a patient population with treatment refractory bipolar disorder.
- Conditions
- Bipolar Disorder
- Being tested
- Deep Brain Stimulation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Hamilton Depression Rating Scale (HAMD), Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: Change from baseline in depression scores at 3 months, 6 months and 12 months
Secondary outcomes (2)
Young Mania Rating Scale
Significant improvement in Young Mania Rating Scale (YMRS)
Measured: Change from baseline in manic, hypomanic scores at 3 months, 6 months and 12 months
Questionnaires-Quality of Life
Short Form Health Survey (SF36)
Measured: Change from baseline in quality of life scores at 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres M. Lozano, University Health Network, Toronto
- Investigators
- Andres M Lozano, MD PhD, Principal investigator, University Health Network, TorontoRoger McIntyre, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476527
- Sponsor's protocol ID
- 10-0696-A
- Status last verified
- Oct 2019
- First submitted
- 15 Nov 2011
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder: Pilot Trial
- ClinicalTrials.gov ID
- NCT01476527
- Acronym / sponsor ID
- 10-0696-A
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bipolar disorder (BD) is a complex and disabling disorder that is among the most challenging diagnoses 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. Detection and diagnosis of BD remains a challenge, as most individuals with BD spend many years misdiagnosed as major depression disorder (MDD), often leading to under-treatment or inappropriate treatment. Several studies have attempted to elucidate features of a major depressive episode that indicate an underlying diagnosis of MDD versus bipolar depression.
During the last fifteen years, there have been significant advances in our understanding of the pathophysiology and relevant neuroanatomy and neurocircuitry underlying mood disorders. Much of that progress has been made as a result of technological advances in neuroimaging, both structural and functional.
Deep Brain Stimulation is a neurosurgical tool has been used for over twenty-five years to treat various neurologic and psychiatric conditions. DBS is believed to work by using small amounts of electricity to disrupt the activity of brain structures that produce troublesome symptoms. In the case of Parkinson's disease, DBS is successful in treating the tremor and general slowing that are major parts of that condition. DBS has also been used in psychiatric patients, both as part of treatment, in cases of Obsessive-Compulsive Disorder (OCD), and research, in cases of Depression. 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 dysfunctional anatomic structures subserve both MDD and BD, indicating that modulation of key structures, can lead to an amelioration of symptoms and mood stabilization.
Our primary objective is to establish the safety of deep brain stimulation in a patient population with treatment refractory bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Procedure: Deep Brain StimulationDeep 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
- No neurological disease
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationDeep 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 or surgery | Deep Brain Stimulation |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: Change from baseline in depression scores at 3 months, 6 months and 12 months
Hamilton Depression Rating Scale (HAMD), Montgomery-Åsberg Depression Rating Scale (MADRS)
2 secondary outcomes
Young Mania Rating Scale
Time frame: Change from baseline in manic, hypomanic scores at 3 months, 6 months and 12 months
Questionnaires-Quality of Life
Time frame: Change from baseline in quality of life scores at 3 months, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres M Lozano, MD PhD principal investigator
University Health Network, Toronto
Roger McIntyre, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Bipolar Disorder, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (time frame: Change from baseline in depression scores at 3 months, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.