New brain zapping schedule shows promise for stubborn bipolar depression
NCT ID NCT03953417
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small pilot study tested an accelerated version of theta-burst stimulation, a type of magnetic brain stimulation, in 7 adults with bipolar depression that didn't respond to standard treatments. All participants received the active treatment, and researchers measured changes in depression and mania symptoms. The goal was to see if a faster treatment schedule could safely ease depression.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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7 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Dec 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Stanford University
Palo Alto, California, 94305, United States
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