Clinical trial NCT03953417: Pilot Accelerated Theta Burst in Treatment-Resistant Bipolar Depression
Official title: Pilot Accelerated Theta Burst Stimulation in Treatment-Resistant Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Depression
Keywords: Bipolar Disorder
Treatment Resistant Depression
Transcranial Magnetic Stimulation (TMS)
Theta Burst
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 minutes over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real-world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session over 4-6 weeks). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. In a recent study, the investigators applied this accelerated paradigm in individuals with treatment-resistant depression (TRD), which showed a significant antidepressant effect (90% remission rate). Additionally, 3 participants from this study carried a bipolar TRD diagnosis and responded at minimum, equally as well, with no adverse events experienced or manic/hypomanic conversion observed during the treatment series. This study intends to further modify the parameters to create a more rapid form of this treatment for bipolar TRD, and look at the change in clinical measures and neuroimaging biomarkers.

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.

Primary outcomes:
measure: Change From Baseline Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline and immediately post-treatment (6 days post baseline)
Secondary outcomes:
measure: Change From Baseline Young Mania Rating Scale (YMRS)
timeFrame: Baseline and immediate post-treatment (6 days post baseline)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Ian Kratter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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