Status:
COMPLETED
Practical Application of Accelerated iTBS for MDD
Lead Sponsor:
Sonder Behavioral Health and Wellness
Conditions:
Major Depressive Disorder
Major Depressive Disorder, Recurrent Episode, Severe
Eligibility:
All Genders
22-70 years
Phase:
NA
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 i...
Detailed Description
The primary objective of this study is to demonstrate the preliminary effectiveness, tolerability, and feasibility of an accelerated, intermittent theta burst stimulation (iTBS) protocol for adults di...
Eligibility Criteria
Inclusion
- Male or female
- 22- 70 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
Exclusion
- 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
- History of rTMS exposure within 6 months of initial study treatment
Key Trial Info
Start Date :
November 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06113575
Start Date
November 23 2022
End Date
July 28 2023
Last Update
November 7 2023
Active Locations (1)
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1
Sonder Behavioral Health and Wellness
Minnetonka, Minnesota, United States, 55343