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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampa One TMS System | Device | Transcranial Magnetic Stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| 9-item Patient Health Questionnaire (PHQ-9) [or PHQ-9-A if appropriate] | 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. | Administered weekly from baseline up to 1 year from the end of treatment. |
| 7-item General Anxiety Disorder Questionnaire (GAD-7) [or GAD-10-A if appropriate] | 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. | Administered weekly from baseline up to 1 year from the end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D) [if administered] | A clinician-administered 17-item scale assessing neurovegetative, mood and hedonic, cognitive, and other symptom domains, widely used in major studies of TMS in depression (Blumberger et al. 2018). | Administered weekly from baseline up to 1 year from the end of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Downar, MD PhD FRCPC | Ampa Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kind Health Group | Encinitas | California | 92024 | United States | ||
| Salience Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37984281 | Background | 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. | |
| 32799106 |
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| Montgomery-Asberg Depression Rating Scale (MADRS) [if administered] |
A 10-item clinician-rated scale assessing emotional, cognitive, and psychomotor aspects of depression, also widely used in TMS research studies (e.g., (O'Reardon et al. 2007; George et al. 2010)). |
| Administered weekly from baseline up to 1 year from the end of treatment. |
| Hamilton Anxiety Rating Scale (HAM-A) [if administered] | A clinician-administered 14-item scale psychological questionnaire used to assess the severity of a person's anxiety; it measures both psychic anxiety and somatic anxiety. | Administered weekly from baseline up to 1 year from the end of treatment. |
| Plano |
| Texas |
| 75093 |
| United States |
| Background |
| 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. |
| 29726344 | Background | 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. |
| 20439832 | Background | 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. |
| 17573044 | Background | 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. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D000098647 | Generalized Anxiety Disorder |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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