NCT03953417Completed
Pilot Accelerated Theta Burst in Treatment-Resistant Bipolar Depression
Pilot Accelerated Theta Burst Stimulation in Treatment-Resistant Bipolar Depression
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 18 Apr 2019
- Start date
- 1 Jul 2019
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Stanford University
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT03953417
What you commit to
- Study type: Interventional
- Participants enrolled: 7
- From 1 Jul 2019 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
- Any change in medication of which the study PI is not aware of.
Other illness
- 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).
- 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.
- 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.
Other
- 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.
- 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.
- Current (or chronic) use of opiates.
- Current psychosis
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.