Bipolar Disorder, ManicNCT04058249
Accelerated Theta Burst Stimulation for Inpatients With Bipolar Disorder
A study testing Accelerated intermittent theta-burst stimulation over right DLPFC in people with Bipolar Disorder, Manic and Bipolar Disorder I, run by Stanford University at 1 site in United States.
Trial summary
This study evaluates the efficacy of an accelerated schedule of theta-burst stimulation for treating manic episodes in bipolar disorder. In this open-label study, all participants will receive accelerated theta-burst stimulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bipolar Disorder, Manic, Bipolar Disorder I
- What is being tested?
- Accelerated intermittent theta-burst stimulation over right DLPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between the ages of 18 and 80 years at the time of screening.
- Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questions and follow instructions during fMRI assessments and aiTBS interventions
- Stated willingness to adhere to all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information
- Primary diagnosis of Bipolar I or II Disorder according to the Diagnosis and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
- Currently experiencing a hypomanic or manic episode according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
- YMRS score of ≥12 at screening.
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- Access to ongoing psychiatric care after completion of the study.
- Must be adherent or agreeable to pharmacotherapy per clinical standard of care at screening.
- Patients who are in both voluntary and involuntary hold.
- In good general health, as evidenced by medical history.
- For females of reproductive potential: use of highly effective contraception.
Who cannot join
- Currently pregnant or breastfeeding.
- Primary psychiatric condition other than Bipolar I or II Disorder requiring treatment other than stable comorbid anxiety disorder.
- Diagnosis of Intellectual Disability or Autism Spectrum Disorder
- Current moderate or severe substance use disorder or demonstrating signs of acute substance intoxication or withdrawal
- Active suicidal ideation (defined as an M-SSI > 8)
- History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
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- Contraindication to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
- Contraindication to MRI (e.g. ferromagnetic metal in their body)
- Treatment with another investigational drug or other intervention within the study period
- Any other condition deemed by the PI to interfere with the study or increase risk to the participant
- Current unmanageable psychosis that the PI believes would interfere with treatment
- Any history of psychosurgery
- Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO).
- Any other condition deemed by the PI to interfere with the study or increase risk to the participant.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the efficacy of an accelerated schedule of theta-burst stimulation for treating manic episodes in bipolar disorder. In this open-label study, all participants will receive accelerated theta-burst stimulation.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 minutes over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real-world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session over 4-6 weeks). Recently, researchers have modified the treatment parameters to reduce treatment times with some preliminary success. In a recent study, an accelerated paradigm showed a significant antidepressant effect (90% remission rate) in individuals with treatment-resistant depression (TRD), in only 5 days. Additionally, 5 participants from this study carried a bipolar diagnosis and responded similarly, with no adverse events experienced or manic/hypomanic conversion observed during the treatment series. In parallel to this, evidence in the literature shows that right prefrontal rapid TMS is safe and efficacious in the treatment of bipolar mania showing laterality opposed to the proposed effect of rapid TMS in depression.
The current trial intends to utilise this modified design, i.e., an accelerated theta burst stimulation treatment over the right prefrontal cortex, for manic episodes in bipolar disorder. The trial also aims to look at the change in clinical measures and neuroimaging biomarkers.
- Conditions
- Bipolar Disorder, Manic, Bipolar Disorder I
- Being tested
- Accelerated intermittent theta-burst stimulation over right DLPFC
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated intermittent theta-burst stimulation over right DLPFCDevice
All participants will receive accelerated intermittent theta-burst stimulation to the right DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
Stimulation will be delivered to right-DLPFC using the Brainsway stimulator.
| Study group | Role | What they receive |
|---|---|---|
| Right DLPFC aiTBS stimulation | Experimental | Not described Receives: Device: Accelerated intermittent theta-burst stimulation over right DLPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
Measured: 6 days
Secondary outcomes (1)
Young Mania Rating Scale [YMRS] Score
The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight), based on the participant's subjective report of his or her condition over the previous 48 hours and the clinician's observations during the interview, with the emphasis on the latter. Seven of the 11 items are rated on a scale of 0-4 and 4 of the items are rated on a scale of 0-8, with higher scores indicating greater severity of symptoms. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms.
Measured: Baseline, day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Nov 2019
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar Disorder, ManicStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bora Kim, Stanford University
- Investigators
- Jean-Marie Batail, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058249
- Sponsor's protocol ID
- 52635
- Status last verified
- Jun 2023
- First submitted
- 5 Aug 2019
- Last updated
- 17 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Theta Burst Stimulation for Inpatients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT04058249
- Acronym / sponsor ID
- 52635
- Conditions
- Bipolar Disorder, Manic, Bipolar Disorder I
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Posted 17 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of an accelerated schedule of theta-burst stimulation for treating manic episodes in bipolar disorder. In this open-label study, all participants will receive accelerated theta-burst stimulation.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 minutes over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real-world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session over 4-6 weeks). Recently, researchers have modified the treatment parameters to reduce treatment times with some preliminary success. In a recent study, an accelerated paradigm showed a significant antidepressant effect (90% remission rate) in individuals with treatment-resistant depression (TRD), in only 5 days. Additionally, 5 participants from this study carried a bipolar diagnosis and responded similarly, with no adverse events experienced or manic/hypomanic conversion observed during the treatment series. In parallel to this, evidence in the literature shows that right prefrontal rapid TMS is safe and efficacious in the treatment of bipolar mania showing laterality opposed to the proposed effect of rapid TMS in depression.
The current trial intends to utilise this modified design, i.e., an accelerated theta burst stimulation treatment over the right prefrontal cortex, for manic episodes in bipolar disorder. The trial also aims to look at the change in clinical measures and neuroimaging biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Right DLPFC aiTBS stimulation | Experimental | Device: Accelerated intermittent theta-burst stimulation over right DLPFC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, between the ages of 18 and 80 years at the time of screening.
- Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questions and follow instructions during fMRI assessments and aiTBS interventions
- Stated willingness to adhere to all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information
- Primary diagnosis of Bipolar I or II Disorder according to the Diagnosis and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
- Currently experiencing a hypomanic or manic episode according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
Key exclusion criteria (14 listed)
- Currently pregnant or breastfeeding.
- Primary psychiatric condition other than Bipolar I or II Disorder requiring treatment other than stable comorbid anxiety disorder.
- Diagnosis of Intellectual Disability or Autism Spectrum Disorder
- Current moderate or severe substance use disorder or demonstrating signs of acute substance intoxication or withdrawal
- Active suicidal ideation (defined as an M-SSI > 8)
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 |
|---|---|---|
| Accelerated intermittent theta-burst stimulation over right DLPFCAll participants will receive accelerated intermittent theta-burst stimulation to the right DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to right-DLPFC using the Brainsway stimulator. | Device | Right DLPFC aiTBS stimulation |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: 6 days
1 secondary outcome
Young Mania Rating Scale [YMRS] Score
Time frame: Baseline, day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jean-Marie Batail, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated intermittent theta-burst stimulation over right DLPFC in people with Bipolar Disorder, Manic and Bipolar Disorder I, run by Stanford University at 1 site in United States.
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 11 inclusion and 14 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: stopped early, as of the sponsor's last update on 17 Jul 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment Emergent Adverse Events (time frame: 6 days). 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 17 Jul 2023.