N/A
N=7
Pilot Accelerated Theta Burst in Treatment-Resistant Bipolar Depression
Treatment Resistant Depression
Bottom Line
View on ClinicalTrials.gov: NCT03953417 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change From Baseline Montgomery Asberg Depression Rating Scale (MADRS) — 40.0; 5.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Accelerated intermittent theta-burst treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Montgomery Asberg Depression Rating Scale (MADRS) |
40.0; 5.7 | — |
| SECONDARY Change From Baseline Young Mania Rating Scale (YMRS) |
0.8; 0 | — |
Summary
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant bipolar depression. In this open-label study, all participants will receive accelerated theta-burst stimulation.
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 to 80 years of age.
- Able to provide informed consent.
- Diagnosed with Bipolar Disorder and currently experiencing a Major Depressive Episode (MDE).
- Meet the threshold on the total MADRS score of >/=20 at baseline.
- In good general health, as ascertained by medical history.
- If female, a status of non-childbearing potential or use of an acceptable form of birth control.
- History of rTMS failure with FDA approved rTMS parameters is permitted.
Exclusion Criteria
- Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
- Female that is pregnant or breastfeeding.
- Female with a positive pregnancy test at participation.
- Total MADRS score of < 20 at study entry.
- Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence.
- Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific Phobia (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
- History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
- Any Axis I or Axis II Disorder, which at screening is clinically predominant to their bipolar depression or has been predominant to their bipolar depression at any time within six months prior to screening.
- Considered at significant risk for suicide during the course of the study.
- Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
- Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
- Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
- History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
- Current (or chronic) use of opiates.
- History of epilepsy.
- History of shrapnel or metal in the head or skull.
- History of cardiovascular disease or cardiac event.
- History of OCD.
- History of autism spectrum disorder.
- Current psychosis
- Any change in medication of which the study PI is not aware of.
Data sourced from ClinicalTrials.gov (NCT03953417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.