Pilot Accelerated Theta Burst Stimulation in Treatment-Resistant Bipolar Depression
Overview
- Phase
- Not Applicable
- Intervention
- Accelerated intermittent theta-burst treatment
- Conditions
- Treatment Resistant Depression
- Sponsor
- Stanford University
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Change From Baseline Montgomery Asberg Depression Rating Scale (MADRS)
- Status
- Completed
- Last Updated
- 2 months ago
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.
Investigators
Ian Kratter
Clinical Assistant Professor, Department of Psychiatry and Behavioral Sciences, Stanford University Medical Center
Stanford University
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.
Arms & Interventions
Accelerated intermittent theta burst treatment
All participants will receive accelerated intermittent theta-burst stimulation.
Intervention: Accelerated intermittent theta-burst treatment
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))