Pilot Accelerated Theta Burst Stimulation in Treatment-Resistant Bipolar Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Change From Baseline Montgomery Asberg Depression Rating Scale (MADRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Accelerated intermittent theta burst treatment
All participants will receive accelerated intermittent theta-burst stimulation.
Intervention: Accelerated intermittent theta-burst treatment (Device)
Outcomes
Primary Outcomes
Change From Baseline Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline and immediately post-treatment (6 days post baseline)
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS consists of ten questions. Each interview question is rated from 0 to 6 with an overall score of 60 or less. Higher scores indicate increasing depressive symptoms. A total score of 0 to 6 indicates the absents of depressive symptoms, 7 to 19 indicates mild depressive symptoms, 30 to 34 indicates moderate depressive symptoms, 35 to 60 indicates severe depressive symptoms.
Secondary Outcomes
- Change From Baseline Young Mania Rating Scale (YMRS)(Baseline and immediate post-treatment (6 days post baseline))
Investigators
Ian Kratter
Clinical Assistant Professor, Department of Psychiatry and Behavioral Sciences, Stanford University Medical Center
Stanford University