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N/A N=7 Treatment

Pilot Accelerated Theta Burst in Treatment-Resistant Bipolar Depression

Treatment Resistant Depression

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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