Bipolar Depression, Bipolar I Disorder
Conditions
Brief summary
A multisite, open label pilot study to investigate the efficacy and safety of a novel accelerated intermittent theta-burst stimulation (iTBS) protocol while assessing for changes in neuroimaging biomarkers associated with treatment response.
Interventions
DEVICEMagnus Transcranial Magnetic Neuromodulation System (MNS) with SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy)
Novel intermittent theta burst stimulation protocol with individualized targets in the brain for stimulation using structural and functional MRI inputs
Sponsors
Baszucki Brain Research Fund
Magnus Medical
University of Texas at Austin
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 22-65 years of age 2. Bipolar I disorder diagnosis as defined by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) 3. Currently experiencing a Major Depressive Episode with Montgomery-Asberg Depression Rating Scale (MADRS) \>/= 20 at screening \[Day -5/-14\] and baseline \[Day 0\] 4. On a stable and adequate dose of an anti-manic agent (Lithium with a level of at least 0.6, Depakote with a level of at least 50, or a therapeutic dose of carbamazepine, oxcarbazepine, or a neuroleptic for treatment of mania per clinician judgment) without dose changes for at least 6 weeks prior to the active study time period. Final assessment of appropriateness of participant's pharmacologic regimen is subject to study team clinician judgment. 5. Having failed a therapeutic trial of a first line bipolar depression antidepressant (as specified by the Antidepressant Treatment History Form and updated with new medications approved by the FDA for treatment of bipolar depression) in this current episode. This includes a minimum 4 week trial of one of the following medications (minimum dosage): lithium 900mg daily (or blood level \>= 0.6 milliequivalent/Liter (mEq/L), carbamazepine 400mg daily (or blood level \>= 0.8 mEq/L), lamotrigine 200mg daily, asenapine 20mg daily, lurasidone 20mg daily, olanzapine 10mg daily, quetiapine 300mg daily, or lumateperone 42mg daily. Final determination of a failed adequate therapeutic trial is subject to study team clinician judgement. 6. Established outpatient psychiatrist
Exclusion criteria
1. Female that is pregnant or breastfeeding, or of childbearing potential but not using medically acceptable birth control during study 2. Current mixed episode assessed by clinician judgment as defined by DSM-5 criteria 3. Current active substance use disorder (as defined by DSM-5) with exception of nicotine and caffeine. Participants may be subject to urine drug screen base on study team clinician judgment. 4. Participation in any clinical trial with an investigational drug or device within the last 3 month or concurrent to study participation 5. History of epilepsy, shrapnel or metal in the head or skull, cardiovascular disease/event, Obsessive Compulsive Disorder, or autism spectrum disorder 6. Clinically defined major neurological disorder; including, but not limited to, seizure disorder and history of loss of consciousness due to head injury for greater than 10 minutes, or documented evidence of brain injury 7. Active suicidal risk based on investigator's clinical judgment 8. Clinically significant unstable medical condition 9. Other condition judged by investigator that could prevent the participant from completion of the study (such as but not limited to, significant physical disability (e.g., hearing/visual deficits) to perform a neutral memory task and/or neuropsychological test battery) 10. Ferromagnetic metal implant or another contraindication to imaging in a 3 Tesla MRI 11. Electroconvulsive therapy (ECT) treatment in the past 3 months 12. Minimum of 6 months since last manic or hypomanic episode as defined by DSM-5 criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score | baseline and post treatment up to 5 days | The MADRS is a ten-item clinician rated questionnaire that helps rate the severity of depression. Total scores can range from 0 to 60, with higher scores indicating greater severity of depression (0-6 normal range, 7-19 mild depression, 20-34 moderate depression, \>34 severe depression). MADRS score will be assessed at baseline visit and immediate follow-up visit (which occurs within 5 days after treatment end). The change in MADRS score is calculated by baseline - immediate follow-up visit score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Open label study, all participants will receive novel iTBS protocol, SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy) | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Montgomery-Asberg Depression Rating Scale (MADRS) Score | 29.8 score on a scale STANDARD_DEVIATION 5.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score
The MADRS is a ten-item clinician rated questionnaire that helps rate the severity of depression. Total scores can range from 0 to 60, with higher scores indicating greater severity of depression (0-6 normal range, 7-19 mild depression, 20-34 moderate depression, \>34 severe depression). MADRS score will be assessed at baseline visit and immediate follow-up visit (which occurs within 5 days after treatment end). The change in MADRS score is calculated by baseline - immediate follow-up visit score.
Time frame: baseline and post treatment up to 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score | 16.9 score on a scale | Standard Deviation 6.7 |