Clinical trial NCT06512324: Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry
Official title: Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry (OBSERVER)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Major Depressive Disorder
MDD
Generalized Anxiety Disorder
GAD
Depression
Anxiety
Keywords: Transcranial Magnetic Stimulation
TMS
Noninvasive Brain Stimulation
Accelerated Protocol
Stimulation Parameters
Patient Health Questionnaire
Behavioral Factors
Physiological Factors
Generalized Anxiety Disorder 7-item Scale
PHQ-9
PHQ9
GAD-7
GAD7
Longitudinal Observational Study
Registry
Patient Characteristics
Pharmacological Factors
United States of America
USA, US
Canada
Hamilton Depression Rating Scale
Montgomery-Asberg Depression Rating Scale
Hamilton Anxiety Rating Scale
Generalized Anxiety Disorder 10-item Scale for Adolescents
GAD-10-A, GAD-10A, GAD10, GAD10A
Patient Health Questionnaire for Adolescents
PHQ-9A, PHQ9A
Lead sponsor: Biomedical Discoveries and Neuroscientific Foundations LLC
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 5000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include male, female, and nonbinary patients who are experiencing symptoms of depression and/or anxiety and who have elected to undergo TMS treatment at a participating TMS treatment site, after having been deemed suitable for treatment by their prescribing physician. Participants will have voluntarily chosen to undergo a clinical course of TMS treatment at participating between June 27, 2024, to December 31, 2029. Eligible individuals must be 12 years or older, and participation is limited to those who understand English due to the availability of an English-only informed consent form (ICF).

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:

1. Which factors have the greatest causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)?
2. 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.


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.

Primary outcomes:
measure: 9-item Patient Health Questionnaire (PHQ-9) [or PHQ-9-A if appropriate]
timeFrame: Administered weekly from baseline up to 1 year from the end of treatment.
measure: 7-item General Anxiety Disorder Questionnaire (GAD-7) [or GAD-10-A if appropriate]
timeFrame: Administered weekly from baseline up to 1 year from the end of treatment.
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HAM-D) [if administered]
timeFrame: Administered weekly from baseline up to 1 year from the end of treatment.
measure: Montgomery-Asberg Depression Rating Scale (MADRS) [if administered]
timeFrame: Administered weekly from baseline up to 1 year from the end of treatment.
measure: Hamilton Anxiety Rating Scale (HAM-A) [if administered]
timeFrame: Administered weekly from baseline up to 1 year from the end of treatment.
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Kind Health Group
state: California
city: Plano
country: United States
facility: Salience Research Institute
state: Texas
Study officials:
affiliation: Ampa Health Inc
name: Jonathan Downar, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leuchter MK, Citrenbaum C, Wilson AC, Tibbe TD, Jackson NJ, Krantz DE, Wilke SA, Corlier J, Strouse TB, Hoftman GD, Tadayonnejad R, Koek RJ, Slan AR, Ginder ND, Distler MG, Artin H, Lee JH, Adelekun AE, Leuchter AF. A comparison of self- and observer-rated scales for detecting clinical improvement during repetitive transcranial stimulation (rTMS) treatment of depression. Psychiatry Res. 2023 Dec;330:115608. doi: 10.1016/j.psychres.2023.115608. Epub 2023 Nov 14.
citation: Sackeim HA, Aaronson ST, Carpenter LL, Hutton TM, Mina M, Pages K, Verdoliva S, West WS. Clinical outcomes in a large registry of patients with major depressive disorder treated with Transcranial Magnetic Stimulation. J Affect Disord. 2020 Dec 1;277:65-74. doi: 10.1016/j.jad.2020.08.005. Epub 2020 Aug 7.
citation: Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
citation: George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
citation: O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.