Major Depressive DisorderOBSERVERNCT06512324
Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry
An observational study of Major Depressive Disorder and MDD, run by Biomedical Discoveries and Neuroscientific Foundations LLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Major Depressive Disorder, MDD, Generalized Anxiety Disorder
- What is being tested?
- Ampa One TMS System
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2024to 31 Dec 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Kind Health Group
Encinitas, California, 92024
Salience Research Institute
Plano, Texas, 75093
About this study
Official title: Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry (OBSERVER)
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.
- Conditions
- Major Depressive Disorder, MDD, Generalized Anxiety Disorder, GAD, Depression, Anxiety
- Being tested
- Ampa One TMS System
- 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
- Medical subject headings
- Depressive Disorder, Major, Generalized Anxiety Disorder, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ampa One TMS SystemDevice
Transcranial Magnetic Stimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Administered weekly from baseline up to 1 year from the end of treatment.
Secondary outcomes (3)
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).
Measured: Administered weekly from baseline up to 1 year from the end of treatment.
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)).
Measured: 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.
Measured: Administered weekly from baseline up to 1 year from the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start27 Jun 2024
- Primary completion30 Aug 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Biomedical Discoveries and Neuroscientific Foundations LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Downar, MD PhD FRCPC, Principal investigator, Ampa Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512324
- Sponsor's protocol ID
- BDNF-001
- Acronym
- OBSERVER
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37984281Sackeim 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.
PubMed 32799106Blumberger 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.
PubMed 29726344George 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.
PubMed 20439832O'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.
PubMed 17573044
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry (OBSERVER)
- ClinicalTrials.gov ID
- NCT06512324
- Acronym / sponsor ID
- OBSERVER / BDNF-001
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Biomedical Discoveries and Neuroscientific Foundations LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ampa One TMS SystemTranscranial Magnetic Stimulation | Device | – |
Primary outcome
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.
3 secondary outcomes
Hamilton Depression Rating Scale (HAM-D) [if administered]
Time frame: Administered weekly from baseline up to 1 year from the end of treatment.
Montgomery-Asberg Depression Rating Scale (MADRS) [if administered]
Time frame: Administered weekly from baseline up to 1 year from the end of treatment.
Hamilton Anxiety Rating Scale (HAM-A) [if administered]
Time frame: Administered weekly from baseline up to 1 year from the end of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 37984281Leuchter 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.
- Background: PubMed 32799106Sackeim 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.
- Background: PubMed 29726344Blumberger 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.
- Background: PubMed 20439832George 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.
- Background: PubMed 17573044O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Downar, MD PhD FRCPC principal investigator
Ampa Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and MDD, run by Biomedical Discoveries and Neuroscientific Foundations LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06512324, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.