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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05228457
Other study ID # 850359
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date February 19, 2024

Study information

Verified date March 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. The null hypothesis is that there will be no difference in reductions in depressive symptoms by the end of a five-day treatment period. The alternative hypothesis is that, compared with sham, active TMS will result in a greater reduction in depressive symptoms by the end of the treatment period. Participants will be randomly assigned to active or sham conditions: 50% to active and 50% to sham.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date February 19, 2024
Est. primary completion date February 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Intensive intermittent theta-burst stimulation (iTBS)
Intensive iTBS is intermittent theta-burst stimulation (iTBS), a patterned form of repetitive transcranial magnetic stimulation (rTMS) over a specific brain region.

Locations

Country Name City State
United States Center for Neuromodulation in Depression and Stress, University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical efficacy of high dose spaced theta burst (HDS-TBS) The primary outcome will be based on the set of repeated Montgomery Asberg Depression scores (10 items rated on a 0-6 scale, 0-60 possible score range, with higher scores indicating greater depressive symptomology), obtained at baseline and on each of the five treatment days. Through study completion, approximately 1 week
Secondary Relationship between change in brain resting state functional connectivity and treatment effects The main secondary outcome will be the change in correlation of the dorsal lateral prefrontal cortex (DLPFC) with limbic regions, as gathered during baseline and post stimulation MRI scans. Upon study completion, approximately 1 week
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