Accelerated Theta Burst Stimulation for Inpatients With Bipolar Disorder

NCT04058249 | Terminated Results FDA Device

• 1 other identifier: 52635
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 accelerated theta-burst stimulation.

Conditions

Bipolar Disorder, Manic; Bipolar Disorder I

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  6 days

Secondary Outcomes (1)

• Young Mania Rating Scale [YMRS] Score

  Baseline, day 6

Study Arms (1)

Right DLPFC aiTBS stimulation

EXPERIMENTAL

Device: Accelerated intermittent theta-burst stimulation over right DLPFC

Interventions

Accelerated intermittent theta-burst stimulation over right DLPFC DEVICE

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.

Right DLPFC aiTBS stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Protocol Director
• Organization: Stanford University

brainstimulationstudy@stanford.edu

650-800-6920

Study Officials

• Jean-Marie Batail, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Post-Doctoral Scholar, Stanford University

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 15, 2019
• Study Start: November 1, 2019
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)