Major Depressive Disorder (MDD)NCT05541302
Retrospective TMS Therapy for Adults With MDD
An observational study of Major Depressive Disorder (MDD), run by Neuronetics.
Trial summary
Examine change in the magnitude of antidepressant effects as a function of number of TMS sessions and to determine whether extended treatment courses, beyond 30 and beyond 36 TMS sessions, result in improved efficacy. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- TMS
- Type of treatment
- Medical device
- How many people
- 6,456 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2008to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population comprises patients who were treated with Extended NeuroStar TMS Therapy for MDD on or after November 8, 2008, and whose treatment information was entered in the Neuronetics TrakStar registry at one of the qualifying participating study sites, and for whom the pre-specified required data elements are available in the TrakStar registry and who satisfy each of the study inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Male or female.
- At least 18 years of age.
- Treatment with NeuroStar TMS Therapy.
- Treatment date of November 01, 2008 or later.
- Patient received at least one treatment with NeuroStar TMS Therapy according to standardized NeuroStar TMS Therapy treatment protocols.
- Primary diagnosis of Major Depressive Disorder (MDD) with no comorbid diagnosis.
- PHQ-9 scores available at baseline (pre-treatment).
- Moderate or greater depression prior to the initial treatment course with NeuroStar TMS Therapy, defined as baseline score on the Physician Health Questionnaire-9 (PHQ- 9) ≥ 10.
Who cannot join
None listed.
About this study
Official title: A Retrospective Registry Study to Evaluate Extended NeuroStar® TMS Therapy for Adults With Major Depressive Disorder (MDD)
Examine change in the magnitude of antidepressant effects as a function of number of TMS sessions and to determine whether extended treatment courses, beyond 30 and beyond 36 TMS sessions, result in improved efficacy.
Read the detailed description
The efficacy of TMS in major depressive disorder (MDD) has markedly improved since the pivotal sham-controlled trials. While this enhanced efficacy has been attributed to use of longer treatment courses, the impact of number of treatment sessions on efficacy has not been adequately evaluated. The study device is the Neuronetics, Inc. NeuroStar® TMS Therapy System (K160703, K201158).The study is a retrospective analysis of real-world data from commercial centers. The data will be gathered from the Neuronetics database called TrakStar which collects records of each patient's treatment. The data will be used only as applicable to the objectives of this study.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- TMS
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Transcranial Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| 1-20 TMS sessions | PHQ 9 ratings during this treatment period Receives: Device: TMS | |
| 21 - 29 TMS sessions | PHQ 9 ratings during this treatment period Receives: Device: TMS | |
| 30 TMS Sessions | PHQ 9 ratings during this treatment period Receives: Device: TMS | |
| 31-36 TMS Sessions | PHQ 9 ratings during this treatment period Receives: Device: TMS | |
| extended treatment 36 and beyond | PHQ 9 ratings during this treatment period Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
The primary objective of this study are to evaluate the changes in the Patient Health Questionnaire-9 (PHQ-9) total score.
and the rating of Clinical Global Impression - Severity (CGI-S) score following application of extended NeuroStar TMS Therapy compared to baseline.
Measured: 1 to > 36 sessions for acute treatment sessions or > 6 weeks.
Primary Objective
The primary objective of this study are to evaluate the rating of Clinical Global Impression - Severity (CGI-S) score following application of extended NeuroStar TMS Therapy compared to baseline.
Measured: 1 to > 36 sessions for acute treatment sessions or > 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Nov 2008
- Primary completion30 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 6,456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronetics
- Sponsor type
- University, hospital or other
- Collaborators
- Southern California TMS Center, Brown University, TMS of South Tampa, Sheppard Pratt Health System, Nashville NeuroCare Therapy, NAMSA, Columbia University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541302
- Sponsor's protocol ID
- 44-50018-000
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Registry Study to Evaluate Extended NeuroStar® TMS Therapy for Adults With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT05541302
- Acronym / sponsor ID
- 44-50018-000
- Conditions
- Major Depressive Disorder (MDD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,456 participants (actual)
- Lead sponsor
- NeuroneticsUniversity, hospital or other
- Collaborators
- Southern California TMS Center, Brown University, TMS of South Tampa, Sheppard Pratt Health System, Nashville NeuroCare Therapy, NAMSA, Columbia University
- Study start
- 1 Nov 2008 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 15 Sep 2022 (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.
Examine change in the magnitude of antidepressant effects as a function of number of TMS sessions and to determine whether extended treatment courses, beyond 30 and beyond 36 TMS sessions, result in improved efficacy.
Detailed description
The efficacy of TMS in major depressive disorder (MDD) has markedly improved since the pivotal sham-controlled trials. While this enhanced efficacy has been attributed to use of longer treatment courses, the impact of number of treatment sessions on efficacy has not been adequately evaluated. The study device is the Neuronetics, Inc. NeuroStar® TMS Therapy System (K160703, K201158).The study is a retrospective analysis of real-world data from commercial centers. The data will be gathered from the Neuronetics database called TrakStar which collects records of each patient's treatment. The data will be used only as applicable to the objectives of this study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1-20 TMS sessions | – | Device: TMSPHQ 9 ratings during this treatment period |
| 21 - 29 TMS sessions | – | Device: TMSPHQ 9 ratings during this treatment period |
| 30 TMS Sessions | – | Device: TMSPHQ 9 ratings during this treatment period |
| 31-36 TMS Sessions | – | Device: TMSPHQ 9 ratings during this treatment period |
| extended treatment 36 and beyond | – | Device: TMSPHQ 9 ratings during this treatment period |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population comprises patients who were treated with Extended NeuroStar TMS Therapy for MDD on or after November 8, 2008, and whose treatment information was entered in the Neuronetics TrakStar registry at one of the qualifying participating study sites, and for whom the pre-specified required data elements are available in the TrakStar registry and who satisfy each of the study inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (8 listed)
- Male or female.
- At least 18 years of age.
- Treatment with NeuroStar TMS Therapy.
- Treatment date of November 01, 2008 or later.
- Patient received at least one treatment with NeuroStar TMS Therapy according to standardized NeuroStar TMS Therapy treatment protocols.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TMSTranscranial Magnetic Stimulation | Device | 1-20 TMS sessions, 21 - 29 TMS sessions, 30 TMS Sessions, 31-36 TMS Sessions, extended treatment 36 and beyond |
Primary outcome
Primary Objective
Time frame: 1 to > 36 sessions for acute treatment sessions or > 6 weeks.
The primary objective of this study are to evaluate the changes in the Patient Health Questionnaire-9 (PHQ-9) total score. and the rating of Clinical Global Impression - Severity (CGI-S) score following application of extended NeuroStar TMS Therapy compared to baseline.
Primary Objective
Time frame: 1 to > 36 sessions for acute treatment sessions or > 6 weeks.
The primary objective of this study are to evaluate the rating of Clinical Global Impression - Severity (CGI-S) score following application of extended NeuroStar TMS Therapy compared to baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD), run by Neuronetics.
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 0 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: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Objective (time frame: 1 to > 36 sessions for acute treatment sessions or > 6 weeks.). 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?
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 15 Sep 2022.