iTBS in Bipolar I Depression

Bipolar Depression Clinical Trial

Official title:

A Pilot Study of iTBS in Bipolar I Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05375214
• Other study ID #: IRB00327675
• Status: Completed
• Phase: N/A
• Start date: March 3, 2023
• Est. completion date: November 22, 2023

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 22, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Bipolar I Disorder
• Depression
• Depressive Disorder

Intervention

Device:
• Magnus 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

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Baszucki Brain Research Fund, Magnus Medical, University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29. — View Citation

Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline, at post treatment up to 5 days