NCT05228457Completed
Intensive TMS for Bipolar Depression
Intensive TMS for Rapid Relief of Bipolar Depression Symptoms
Source: ClinicalTrials.gov · Last updated 12 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 13 Jan 2022
- Start date
- 1 Mar 2022
- Primary completion date
- 19 Feb 2024
- Lead sponsor
- University of Pennsylvania
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT05228457
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 1 Mar 2022 to the primary completion date, 19 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No current substance abuse disorder for the past 6 months (previous substance abuse not exclusionary)
- Currently using benzodiazepines (such as lorazepam) with a dose \>1 mg per day or equivalent.
Other illness
- 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
- 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
Other
- 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)
Who the study is looking for
- 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)
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Neuromodulation in Depression and Stress, University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.