Status:
TERMINATED
Accelerated Theta Burst Stimulation for Inpatients With Bipolar Disorder
Lead Sponsor:
Stanford University
Conditions:
Bipolar Disorder, Manic
Bipolar Disorder I
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 acceler...
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 ove...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04058249
Start Date
November 1 2019
End Date
December 20 2021
Last Update
July 17 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford Hospital
Palo Alto, California, United States, 94304