Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry (OBSERVER)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Biomedical Discoveries and Neuroscientific Foundations LLC
- Enrollment
- 5000
- Locations
- 2
- Primary Endpoint
- 9-item Patient Health Questionnaire (PHQ-9) [or PHQ-9-A if appropriate]
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
The goal of this observational study is to record and analyze factors putatively affecting the clinical outcomes among patients undergoing transcranial magnetic stimulation (TMS) treatment for major depressive disorder (MDD) or generalized anxiety disorder (GAD). The main questions it aims to answer are:
- Which factors have the greatest causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)?
- Which factors have a minimal causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)?
Participants already undergoing TMS as part of their treatment plan for MDD/GAD answer survey questions about their symptoms before, during, and up to 1 year post-treatment. Factors affecting clinical outcomes such as stimulation parameters, behavioral factors, physiological factors, patient characteristics, and pharmacological factors, are also recorded.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have a primary diagnosis of major depressive disorder (MDD) and/or generalized anxiety disorder (GAD)
- •Are receiving outpatient care,
- •Voluntarily provide competent consent for treatment,
- •Are 12 years of age or older,
- •Are able to adhere to the weekly assessment schedule for primary outcome measures,
- •Have been assessed by their prescribing physician as suitable candidates for TMS treatment in terms of safety and presenting indication,
- •Have consented to undergo a therapeutic course of TMS treatment at one of the participating clinic sites,
- •Are able to communicate in the English language.
Exclusion Criteria
- •Have been found to have any contraindication to TMS treatment by their prescribing physician,
- •Are considered unsuitable for outpatient care due to illness severity or other factors in the opinion of their prescribing physician,
- •Have active suicidal intent or plan,
- •Are unable to adhere to or decline participation in the weekly assessment schedule for primary outcome measures,
- •Lack the ability to communicate in the English language.
Outcomes
Primary Outcomes
9-item Patient Health Questionnaire (PHQ-9) [or PHQ-9-A if appropriate]
Time Frame: Administered weekly from baseline up to 1 year from the end of treatment.
The PHQ-9 gauges depressive symptoms through its 9-item brief inventory, efficiently quantifying a spectrum of symptoms, including mood, energy, concentration, sleep, appetite, and suicidality. Widely adopted in outpatient care due to its reliability and validity, the PHQ-9 is a well-established tool in TMS practice, and has shown greater likelihood to detect improvement and less likelihood to miss response or remission among patients undergoing TMS treatment (Leuchter et al. 2023). The PHQ-9-A is the adolescent version of the PHQ-9.
7-item General Anxiety Disorder Questionnaire (GAD-7) [or GAD-10-A if appropriate]
Time Frame: Administered weekly from baseline up to 1 year from the end of treatment.
The GAD-7, a concise self-report questionnaire evaluating the severity of Generalized Anxiety Disorder (GAD) symptoms, is comprised of seven items. Respondents rate the frequency of experiences over the past two weeks on a Likert scale, resulting in a total score ranging from 0 to 21. The GAD-7 is a streamlined and effective measure, capturing core symptoms such as excessive worrying, restlessness, irritability, muscle tension, and sleep disturbances. It is likewise widely used in real-world TMS practices and registries of TMS outcomes (Sackeim et al. 2020). The GAD-10-A is the adolescent version of the GAD-7.
Secondary Outcomes
- Hamilton Anxiety Rating Scale (HAM-A) [if administered](Administered weekly from baseline up to 1 year from the end of treatment.)
- Montgomery-Asberg Depression Rating Scale (MADRS) [if administered](Administered weekly from baseline up to 1 year from the end of treatment.)
- Hamilton Depression Rating Scale (HAM-D) [if administered](Administered weekly from baseline up to 1 year from the end of treatment.)