Intensive TMS for Bipolar Depression

University of Pennsylvania34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Bipolar Depression Treatment Resistant Depression

Interventions

Intensive intermittent theta-burst stimulation (iTBS)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Center for Neuromodulation in Depression and Stress, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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, on each of the five treatment days and post TMS.

Time frame: Through study completion, approximately 1 week

Secondary Outcomes

Relationship Between Change in Brain Resting State Functional Connectivity and Treatment Effects

The secondary outcome will be the change in the correlation between the dorsolateral prefrontal cortex (DLPFC) and the subgenual anterior cingulate cortex (sgACC) with the Montgomery-Åsberg Depression Rating Scale (MADRS), as assessed through MRI scans conducted at baseline and post-stimulation. Additionally, the change in the correlation within the entire Default Mode Network (DMN) intraconnectivity and MADRS will be measured for both groups (Active vs. Sham). The correlation is measured on a scale from -1 to +1, where -1 indicates the highest negative anticorrelation, +1 represents the highest positive correlation, and 0 signifies no correlation. MADRS is used to assess the clinical effect.

Time frame: Upon study completion, approximately 1 week

Data from ClinicalTrials.gov

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