Clinical trial NCT05228457: Intensive TMS for Bipolar Depression
Official title: Intensive TMS for Rapid Relief of Bipolar Depression Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Depression
Treatment Resistant Depression
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Clinical Efficacy of High Dose Spaced Theta Burst (HDS-TBS)
timeFrame: Through study completion, approximately 1 week
Secondary outcomes:
measure: Relationship Between Change in Brain Resting State Functional Connectivity and Treatment Effects
timeFrame: Upon study completion, approximately 1 week
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Neuromodulation in Depression and Stress, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Yvette Sheline, MD
role: PRINCIPAL_INVESTIGATOR
References: