N/A
N=26
Intensive TMS for Bipolar Depression
Bipolar Depression · Treatment Resistant Depression
Bottom Line
View on ClinicalTrials.gov: NCT05228457 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Clinical Efficacy of High Dose Spaced Theta Burst (HDS-TBS) — 30.4; 28; 10.5; 25.3 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intensive intermittent theta-burst stimulation (iTBS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Efficacy of High Dose Spaced Theta Burst (HDS-TBS) |
30.4; 28; 10.5; 25.3; 26.7; 26.8 | <0.001 sig |
| SECONDARY Relationship Between Change in Brain Resting State Functional Connectivity and Treatment Effects |
-0.63; 0.33; 0.15; -0.43 | 0.04 sig |
Summary
The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression who have failed (or not shown signs of improvement) after at least two prior treatments.
Eligibility Criteria
Inclusion Criteria
- Bipolar depression (BP I and BP II) by Diagnostic and Statistical Manual 5 (DSM 5) criteria
- Age 18-70
- Right or left handed
- All genders
- Treatment resistant depression, as in they must have treatment resistant depression with 2 or more prior antidepressant trials that have failed to produce a response (> 50% reduction in symptoms) using ATHF criteria
- Able to provide informed consent to participate in the study
- Must be on a stable medication regimen, requiring at least one mood stabilizer
- Depression severity as represented by scoring at least 20 on Montgomery-Asberg Depression Rating Scale (MADRS)
Exclusion Criteria
- No current substance abuse disorder for the past 6 months (previous substance abuse not exclusionary)
- Any psychotic disorder or current active psychotic symptoms (personality disorders not exclusionary unless in the opinion of the referring psychiatrist it would jeopardize participation)
- No dementia or other major neurological disorders
- Not having depression as primary disorder
- No major medical illness, for example metastatic cancer, end stage renal disease
- Not able to verify contact information. Participants must be able to follow through with the study & must have verified contact information and at least one verified contact
- Pregnancy. While there are no known risks to a fetus this is a new use of TMS, which has not been tested, thus pregnancy is exclusionary
- Score on Young Mania Rating Scale (YMRS) greater than 12 (patients with mixed features have been shown not to respond well to TMS treatment)
- Rapid cycling Bipolar illness (patients with > 4 mood episodes within the past year will be excluded, as they have a higher risk of switch to mania)
- Any implants, conditions, or contraindications that would be deemed unsafe for TMS or MRI
- Currently using benzodiazepines (such as lorazepam) with a dose >1 mg per day or equivalent.
Data sourced from ClinicalTrials.gov (NCT05228457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.