Bipolar DisorderPhase 2/3DBS-BIPONCT01372722
Deep Brain Stimulation (DBS) for Treatment Resistant Bipolar Disorder
A Phase 2/3 study testing DBS Activa PC systems Medtronic and DBS, Activa PC systems Medtronic in people with Bipolar Disorder, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Hypothesis to be tested: Bilateral Deep Brain Stimulation to the Nucleus Accumbens is associated with clinically and statistically significant improvement in patients with treatment resistant bipolar disorder. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- DBS Activa PC systems Medtronic and DBS, Activa PC systems Medtronic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to May 2012
- Phase
- Phase 2/3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-70 years old. • German mother tongue • Ability to provide written informed consent.
- At least one manic or hypomanic episode according to DSM IV previous to onset of last depressive episode.
- Global Assessment of Function (GAF) score of > 46 • 5 years after the first episode of MD • DSM IV criteria for a current Major Depressive Episode (MDE) diagnosed by structured clinical interview for DSM IV. Diagnosis will be confirmed by two independent psychiatrists. • Current episode of MD > two years duration OR a history of more than 4 lifetime depressive episodes. • Minimum score at study entry of 28 on the 24-item Hamilton Depression Rating Scale (HDRS24).
- Average pre-operative HDRS24 score of 28 or greater (averaged over screening period) and a final preoperative HDRS24 score no more than 30% lower than the baseline screening HDRS score. • Treatment-resistant depression defined as: • Failure to respond to a minimum of four different antidepressant treatments, including medications and evidence-based psychotherapy (> 20 sessions with an experienced psychotherapist) administered at adequate doses and duration during the current episode. We will require documentation (i.e., statement from the treating psychiatrist) that a treatment trial has failed (either no response to maximum tolerable doses for a minimum of 5 weeks, or side-effects at sub-maximal doses) as coded by the Antidepressant Treatment History Form (ATHF). The study investigators will document each treatment by way of review of records from referring psychiatrists. • Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode (> 6 bilateral treatments).
- A patient may remain on psychotropic medications during this study. However, doses must remain stable during a one month pre-operative evaluation period, the single blind phase and the open stimulation phase.
- -If currently in psychotherapy, a patient must have been in this therapy for at least six months and continue to attend scheduled visits at no greater or lesser frequency than during the last three months. -
Show all 9Show fewer
- Patients must have an established outpatient psychiatrist.
- Patients are able to fulfill the study requirements.
- Patients are in good general health.
Who cannot join
- Inability to tolerate general anesthesia.
- Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
- Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
- Cerebrovascular risk factors or a previous stroke, documented head trauma or neurodegenerative disorders.
- Other clinically significant Axis I psychiatric diagnoses including schizophrenia, bipolar I disorder (patients with bipolar II disorder will be included), panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder in the previous 12 months. Patients with severe Axis II personality disorders will also be excluded if they have the potential to interfere with cooperation during the pre- and post-operative phases of the study.
- Current psychotic symptoms.
Show all 19Show fewer
- Current mixed episode.
- Evidence of global cognitive impairment.
- Substance abuse or dependence within the last year (except nicotine).
- Active suicidal ideation.
- Pregnancy and women of childbearing age not using effective contraception or currently nursing.
- General contraindications for DBS surgery (impossibility to conduct pre-operative fMRI, infections, claustrophobia, pregnancy, impossibility to stay awake during electrode implantation, medical risks regarding the operation, cardiac pacemaker/defibrillator or other implanted devices).
- Inability or unwillingness to comply with long-term follow-up.
- Patients who are not able to read and understand the consent form, or who are not capable of understanding or giving informed consent to the procedures of the study.
- History of intolerance to stimulation of any area of the body
- Participation in another drug, device or biologics trial within the preceding 30 days.
- Conditions requiring repeated MRI scans
- Conditions requiring diathermy
- Conditions requiring anticoagulant medication
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy - University Hospital
Bonn, 53105
About this study
Official title: Phase I Study of Bilateral DBS to the Nucleus Accumbens (NAcc-DBS) for Treatment Resistant Bipolar Disorder
Hypothesis to be tested:
Bilateral Deep Brain Stimulation to the Nucleus Accumbens is associated with clinically and statistically significant improvement in patients with treatment resistant bipolar disorder.
Overall Objective:
The aim in this interdisciplinary, psychiatric-neurosurgical project is to evaluate safety and efficacy of bilateral Deep Brain Stimulation to the Nucleus Accumbens (NAcc) using the Medtronic Activa RC Neurostimulator in patients with treatment resistant Bipolar Disorder.
- Conditions
- Bipolar Disorder
- Being tested
- DBS Activa PC systems Medtronic, DBS, Activa PC systems Medtronic
- Keywords
- treatment resistant
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS Activa PC systems MedtronicDevice
130Hz, 90us pulsewidth, 4V Amplitude
DBS, Activa PC systems MedtronicDevice
30Hz, 90us pulsewidth, 4V Amplitude
| Study group | Role | What they receive |
|---|---|---|
| Sham then Stimulation | Experimental | Not described Receives: Device: DBS Activa PC systems Medtronic |
| Stimulation then Sham | Experimental | Not described Receives: Device: DBS, Activa PC systems Medtronic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity rated with Montgomery Asberg Depression Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale (abbreviated MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale is.
Measured: 12 month after DBS stimulation onset
Young Mania Rating Scale (YMRS)
One of the most frequently used rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. This scale will be used to assess the development of manic symptoms over time, mainly in order to assess treatment emergent manic symptoms.
Measured: 12 month after DBS stimulation onset
Secondary outcomes (3)
Depression Severity rated with Hamilton Depression Rating Scale (HDRS24)
The Hamilton Rating Scale for Depression (HRSD), also known as the Hamilton Depression Rating Scale (HDRS) or abbreviated to HAM-D, is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. The questionnaire rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. The questionnaire is presently one of the most commonly used scales for rating depression in medical research.
Measured: 12 month after DBS stimulation onset
Adverse Event Schedule
Adverse events induced by the Stimulation will be recorded during the study using a structured questionnaire. 12 months after stimulation onset results will be compiled and rated as being due to DBS or not.
Measured: 12 month after DBS stimulation onset
Comprehensive neuropsychological test battery
- General cognitive functions (Mini-Mental State Examination)
- Attention (d2 attention-burden test)
- Learning and memory tests covering verbal and visual spatial learning, memory and working memory (Verbal Learning and Memory Test, Rey Visual Design Learning Test,Wechsler Memory Scale)
- language (HAWIE lexis tests, HAWIE finding similarities)
- Executive functions (Trail Making Tests, Five-Point Test, and the Stroop test)
- Visual perception (Hooper Visual Organization Test)
Measured: 12 month after DBS stimulation onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startMay 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Other stimulation target (slMFB) more efficacious, unethical to continue with Nucleus Accumbens
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas E. Schlaepfer, MD, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372722
- Sponsor's protocol ID
- BSG-11-4712DBS
- Acronym
- DBS-BIPO
- Status last verified
- Aug 2018
- First submitted
- 6 May 2011
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Bilateral DBS to the Nucleus Accumbens (NAcc-DBS) for Treatment Resistant Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01372722
- Acronym / sponsor ID
- DBS-BIPO / BSG-11-4712DBS
- Conditions
- Bipolar Disorder
- Keywords
- treatment resistant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Other stimulation target (slMFB) more efficacious, unethical to continue with Nucleus Accumbens
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- May 2010 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Jun 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.
Hypothesis to be tested:
Bilateral Deep Brain Stimulation to the Nucleus Accumbens is associated with clinically and statistically significant improvement in patients with treatment resistant bipolar disorder.
Overall Objective:
The aim in this interdisciplinary, psychiatric-neurosurgical project is to evaluate safety and efficacy of bilateral Deep Brain Stimulation to the Nucleus Accumbens (NAcc) using the Medtronic Activa RC Neurostimulator in patients with treatment resistant Bipolar Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham then Stimulation | Experimental | Device: DBS Activa PC systems Medtronic |
| Stimulation then Sham | Experimental | Device: DBS, Activa PC systems Medtronic |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 20-70 years old. • German mother tongue • Ability to provide written informed consent.
- At least one manic or hypomanic episode according to DSM IV previous to onset of last depressive episode.
- Global Assessment of Function (GAF) score of > 46 • 5 years after the first episode of MD • DSM IV criteria for a current Major Depressive Episode (MDE) diagnosed by structured clinical interview for DSM IV. Diagnosis will be confirmed by two independent psychiatrists. • Current episode of MD > two years duration OR a history of more than 4 lifetime depressive episodes. • Minimum score at study entry of 28 on the 24-item Hamilton Depression Rating Scale (HDRS24).
- Average pre-operative HDRS24 score of 28 or greater (averaged over screening period) and a final preoperative HDRS24 score no more than 30% lower than the baseline screening HDRS score. • Treatment-resistant depression defined as: • Failure to respond to a minimum of four different antidepressant treatments, including medications and evidence-based psychotherapy (> 20 sessions with an experienced psychotherapist) administered at adequate doses and duration during the current episode. We will require documentation (i.e., statement from the treating psychiatrist) that a treatment trial has failed (either no response to maximum tolerable doses for a minimum of 5 weeks, or side-effects at sub-maximal doses) as coded by the Antidepressant Treatment History Form (ATHF). The study investigators will document each treatment by way of review of records from referring psychiatrists. • Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode (> 6 bilateral treatments).
- A patient may remain on psychotropic medications during this study. However, doses must remain stable during a one month pre-operative evaluation period, the single blind phase and the open stimulation phase.
Key exclusion criteria (19 listed)
- Inability to tolerate general anesthesia.
- Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome
- Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI)
- Cerebrovascular risk factors or a previous stroke, documented head trauma or neurodegenerative disorders.
- Other clinically significant Axis I psychiatric diagnoses including schizophrenia, bipolar I disorder (patients with bipolar II disorder will be included), panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder in the previous 12 months. Patients with severe Axis II personality disorders will also be excluded if they have the potential to interfere with cooperation during the pre- and post-operative phases of the study.
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 |
|---|---|---|
| DBS Activa PC systems Medtronic130Hz, 90us pulsewidth, 4V Amplitude | Device | Sham then Stimulation |
| DBS, Activa PC systems Medtronic30Hz, 90us pulsewidth, 4V Amplitude | Device | Stimulation then Sham |
Primary outcome
Depression Severity rated with Montgomery Asberg Depression Scale (MADRS)
Time frame: 12 month after DBS stimulation onset
The Montgomery-Åsberg Depression Rating Scale (abbreviated MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale is.
Young Mania Rating Scale (YMRS)
Time frame: 12 month after DBS stimulation onset
One of the most frequently used rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. This scale will be used to assess the development of manic symptoms over time, mainly in order to assess treatment emergent manic symptoms.
3 secondary outcomes
Depression Severity rated with Hamilton Depression Rating Scale (HDRS24)
Time frame: 12 month after DBS stimulation onset
Adverse Event Schedule
Time frame: 12 month after DBS stimulation onset
Comprehensive neuropsychological test battery
Time frame: 12 month after DBS stimulation onset
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Related trials for Bipolar Disorder
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 4
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Depression, Bipolar
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DBS Activa PC systems Medtronic and DBS, Activa PC systems Medtronic in people with Bipolar Disorder, run by University Hospital, Bonn at 1 site in Germany.
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 9 inclusion and 19 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: withdrawn, as of the sponsor's last update on 7 Aug 2018. 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 Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Depression Severity rated with Montgomery Asberg Depression Scale (MADRS) (time frame: 12 month after DBS stimulation onset). The study lists 2 primary outcomes in all. 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 7 Aug 2018.