Clinical trial NCT04657432: Brief, High-dose rTMS for Depression
Official title: Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2020-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study 1: Participants will be randomized to 10 different doses of accelerated intermittent theta burst rTMS for remediation of depression symptoms. The goal is to determine the optimal dose in terms of efficacy while minimizing burden and side effects.

Study 2: Participants will be assigned to 10 active sessions (per treatment day) of accelerated rTMS for 5 treatment days. All doses are active and within established therapeutic levels of rTMS. The goal is to determine the role of individual variations of their functional networks compared to the site of stimulation.
Primary purpose: TREATMENT

Brief summary: High frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe, feasible, and acceptable. Conventionally, rTMS investigations have relied on rational decision trees for dosage determination. The purpose of this study is to systematically examine an accelerated protocol of intermittent theta burst (iTBS). Study 1 aims to provide a quantifiable dose-response curve for iTBS and depressive symptom reduction in major depression. Study 2 aims to determine the role of individual variations of their functional networks compared to the site of stimulation and clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* A negative urine pregnancy test, if female subject of childbearing potential.
* Able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
* After full explanation of the study, willingness of participant is demonstrated by signing the informed consent form.

Exclusion Criteria:

* Clinically unstable medical disease:

  * cardiovascular
  * renal
  * gastrointestinal
  * pulmonary
  * metabolic
  * endocrine
  * other
* CNS disease deemed progressive
* Moderate or severe traumatic brain injury (TBI)
* Pregnant females or those currently breast-feeding.
* Current or history of schizophrenia or other psychotic disorder, except psychosis not otherwise specified (NOS) when the presence of sensory hallucinations is clearly related to the subject's trauma, Bipolar Type I disorder, or dementia:

  * vascular
  * Alzheimer's disease
  * other types
* Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) within 6 days of study entry, with the exception of alcohol use disorder, which, at the discretion of the study team, may be permitted.

See further explanation under protection from risk.

* Active participation or plan for enrollment in another evidence-based psychotherapeutic clinical trial
* Participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and must remain stable throughout participation.
* Currently taking medications that have short half-lives, lower the seizure threshold, and do not have evidence of antidepressant efficacy. These include:

  * high dose theophylline or stimulants such as methylphenidate patients taking bupropion must be on a stable dose and take less than or equal to 300 mg/day. Stable means the same dose for 5 half-lives.
* An implanted device in subject's head (shunt, cochlear implant) and/or metal in subject's head (other than dental implant).
* History of seizures or a seizure disorder.

Primary outcomes:
measure: Depression severity (change in score)
timeFrame: Day 1, post-treatment point of 1 month
measure: Depression severity (change in score)
timeFrame: Day 1, post-treatment point of 1 month
measure: Depression severity (change in score)
timeFrame: Day 1, post-treatment point of 1 month
Secondary outcomes:
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
measure: Comorbid symptom severity, functional impairment, acceptability, and tolerability
timeFrame: Day 1, post-treatment point of 1 month
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: