Practical Application of Accelerated iTBS for MDD

NCT06113575 | Completed FDA Device

• 1 other identifier: SW-001-22
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the feasibility and efficacy of accelerated iTBS in adults diagnosed with Major Depressive Disorder. The main question it aims to answer is: What is the efficacy and tolerability of an accelerated iTBS regimen without radiological imaging in adults who have been diagnosed with Major Depressive Disorder and experience treatment resistant symptoms? Participants will complete 36 iTBS treatments in an accelerated schedule over five days. They will also complete several clinical assessments throughout their enrollment to evaluate their depressive symptoms and response to treatment.

Conditions

Major Depressive Disorder; Major Depressive Disorder, Recurrent Episode, Severe; Major Depressive Disorder, Recurrent, Moderate

Keywords

rTMS; Depression; MDD; TMS; iTBS; Accelerated; Theta Burst

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  Change in Montgomery-Asberg Depression Rating Scale (MADRS) score, Minimum value = 0, Maximum value = 60. Higher score indicates a worse outcome.

  Baseline to four weeks post-treatment

Secondary Outcomes (3)

• Patient Health Questionnaire

  Baseline to four weeks post-treatment

• Hamilton Depression Rating Scale

  Baseline to four weeks post-treatment

• Quick Inventory of Depressive Symptomatology

  Baseline to four weeks post-treatment

Study Arms (1)

Scheduled Treatment Arm

EXPERIMENTAL

5 day treatment course, 36 total treatments and clinical assessments.

Device: NeuroStar TMS

Interventions

NeuroStar TMS DEVICE

NeuroStar TMS treatment - 90-120% of Observed MT, 3 pulses/burst, 5 bursts/sec, 2 sec stimulation, 20 msec interval, 20 trains, 600 total pulses/session for 36 treatments in 5 days. 6 treatments on day 1, 8 treatments on days 2, 3, and 4, 6 treatments on day 5.

Scheduled Treatment Arm

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• years
• Able to provide informed consent
• Diagnosed with major depressive disorder (MDD) and currently experiencing a major depressive episode (MDE)
• Subject failed to respond to at least one prior antidepressant medication
• Subject consented to receive TMS therapy to treat MDD with his or her physician independent of potential participation in this clinical study

You may not qualify if:

• Subject satisfies any one or more of the contraindications for TMS therapy per current treatment guidelines as determined by the PI
• Female with known or suspected pregnancy or is currently breastfeeding
• Total MADRS score of \<20 at the screening or baseline visit
• Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-V-TR), with the exception of nicotine dependence
• History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes
• Any disorder which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening
• Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results
• Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation
• Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation
• Current use of opiates
• History of epilepsy
• History of shrapnel or metal in the head or skull
• History of cardiac event(s)
• History of OCD
• History of autism spectrum disorder

Sponsors & Collaborators

• Sonder Behavioral Health and Wellness: lead

Study Sites (1)

Sonder Behavioral Health and Wellness

Minnetonka, Minnesota, 55343, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence; Lymphoma, Follicular; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• John G. Luehr, MD

  Sonder Behavioral Health and Wellness

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: November 23, 2022
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)