Pilot Accelerated Theta Burst in Treatment-Resistant Bipolar Depression

Completed · Not applicable

Conditions studied: Treatment Resistant Depression

In brief

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.

Key facts

Study ID

NCT03953417

Run by

Stanford University

People needed

7

Starts

2019-07-01

Expected to finish

2023-12-30

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University — Palo Alto, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.