Major Depressive DisorderNCT04217837
Treatment of Major Depressive Disorder in the UK Using TMS Therapy
An observational study of Major Depressive Disorder, run by Neuronetics at 1 site in United Kingdom.
Trial summary
The major objective of this observational study is to describe clinical outcomes of patients in the UK receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Transcranial Magnetic Stimulator
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2020to Feb 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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical Practice
Who may be able to join
- Men or women, age 22 - 70, out-patient
- Participants who meet the DSM-5 clinical diagnostic criteria, in the opinion of the treating clinician, for primary diagnosis of unipolar, non-psychotic MDD. The intended treatment plan uses the labeled treatment parameters for TMS as described in the NeuroStar® System
- Women of child bearing potential must be using a medically accepted reliable means of contraception (for oral contraceptive medication: must be in use for at least 3 months)
- Women of childbearing potential must have a negative pregnancy test at screening using urine dipstick
- Participants must have the capacity to consent to all tests and examinations required by the protocol and must sign a written informed consent document to participate in the study.
Who cannot join
- History of seizures or increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure or history of significant head trauma with loss of consciousness for ≥ 5 minutes
- Inability to locate and quantify a motor threshold as defined in the protocol
- Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the participant's head within 30 cm of the treatment coil excluding the mouth that cannot safely be removed. Examples include: cochlear implants; implanted electrodes/stimulators; aneurysm clips or coils; stents; bullet fragments; jewelry; and hair barrettes
- Any psychiatric disorder which, in the judgement of the Investigator, may hinder the participant from completing the procedures required by the study protocol
- Active or inactive implants (including device leads), including deep brain stimulators, and vagus nerve stimulators
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease
- Known or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurostar Transcranial Magnetic Stimulation (TMS) Advanced Therapy System: Data Management, Analysis, and Reporting Format for Clinical Treatment Utilization and Outcomes in the UK
The major objective of this observational study is to describe clinical outcomes of patients in the UK receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.
Read the detailed description
This is a single-center, naturalistic, observational study following the use of the NeuroStar® Advanced Therapy System and assessment of clinical outcome. The goal is to collect, analyze and report information as aggregated summaries on participants receiving treatment with the NeuroStar® Advanced Therapy System.
- Conditions
- Major Depressive Disorder
- Being tested
- Transcranial Magnetic Stimulator
- Keywords
- Transcranial Magnetic Stimulation, Major Depressive Disorder, MDD, TMS, NeuroStar Advanced Therapy System, Repetitive Transcranial Magnetic Stimulation, rTMS
- 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.
Transcranial Magnetic StimulatorDevice
Also called TMS Therapy, Neurostar
Transcranial magnetic stimulation (TMS) uses a targeted pulsed magnetic field, similar to what is used in an MRI (magnetic resonance imaging) machine. While the patient is awake and alert, NeuroStar TMS Therapy stimulates areas of the brain that are underactive in depression.
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder | Participants who meet the DSM-5 clinical diagnostic criteria, in the opinion of the treating clinician, for primary diagnosis of unipolar, non-psychotic MDD. Receives: Device: Transcranial Magnetic Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression - Severity Scale
The change from baseline to endpoint on the total score for the Clinical Global Impression - Severity scale will be reported for the 6 week 3, 6, 9, and 12 month time points. The 7-point scale requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The scale ranges from 1-7, where a higher score means a worse outcome.
Measured: Baseline, 6 weeks, 3, 6, 9, and 12 months
Secondary outcomes (5)
Patient Health Questionnaire - 9-item Self Report
The change from baseline to endpoint on the total score for the PHQ-9 will be reported for the 6 week, 3, 6, 9, and 12 month time points. The questionnaire assesses degree of depression severity. The scale ranges from total scores of 1-27, where a higher score means a worse outcome.
Measured: Baseline, 6 weeks, 3, 6, 9, and 12 months
Inventory of Depressive Symptomatology - Self Report (IDS-SR)
The change from baseline to endpoint on the total score for the Inventory of Depressive Symptomatology - Self Report will be reported for the 6 week, 3, 6, 9, and 12 month time points. It is a tool designed to screen for depression and measure changes in severity of symptoms. The scale ranges from total score ranges of 0-84, where a higher score means a worse outcome.
Measured: Baseline, 6 weeks, 3, 6, 9, and 12 months
EuroQol 5 Dimensions
The change from baseline to endpoint on the total score for the EuroQol 5 Dimensions will be reported for the 6 week, 3, 6, 9, and 12 month time points. The EuroQol 5 Dimensions questionnaire assesses quality of life and is presented as a health profile.
Measured: Baseline, 6 weeks, 3, 6, 9, and 12 months
Health Resource Utilization Questionnaire (HRU)
The change from baseline in health care service utilization reported on the individual questions contained in the HRU will be reported for the 6 week, 3, 6, 9, and 12 month time points. It is a socioeconomic and quality of life questionnaire. Because changes in individual questions are reported, there is no range of scores. The score ranges from 0-100, where a higher score means a better outcome.
Measured: Baseline, 6 weeks, 3, 6, 9, and 12 months
Short Form 36-item Questionnaire
The change from baseline to endpoint on the Individual Factor Scores and General Medical and Mental Health Composite Scores for the SF-36 will be reported for the 6 week, 3, 6, 9, and 12 month time points. The Short Form 36-item Questionnaire evaluates quality of life outcomes.
Measured: Baseline, 6 weeks, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronetics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Abdelghani, MBBCh, MSc, MRCPsych, Principal investigator, St. Pancras Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217837
- Sponsor's protocol ID
- 44-50011-000
- Status last verified
- Sep 2021
- First submitted
- 2 Jan 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostar Transcranial Magnetic Stimulation (TMS) Advanced Therapy System: Data Management, Analysis, and Reporting Format for Clinical Treatment Utilization and Outcomes in the UK
- ClinicalTrials.gov ID
- NCT04217837
- Acronym / sponsor ID
- 44-50011-000
- Conditions
- Major Depressive Disorder
- Keywords
- Transcranial Magnetic Stimulation, Major Depressive Disorder, MDD, TMS, NeuroStar Advanced Therapy System, Repetitive Transcranial Magnetic Stimulation, rTMS
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NeuroneticsUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 3 Jan 2020 (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 major objective of this observational study is to describe clinical outcomes of patients in the UK receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.
Detailed description
This is a single-center, naturalistic, observational study following the use of the NeuroStar® Advanced Therapy System and assessment of clinical outcome. The goal is to collect, analyze and report information as aggregated summaries on participants receiving treatment with the NeuroStar® Advanced Therapy System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder | – | Device: Transcranial Magnetic StimulatorParticipants who meet the DSM-5 clinical diagnostic criteria, in the opinion of the treating clinician, for primary diagnosis of unipolar, non-psychotic MDD. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical Practice
Key inclusion criteria (5 listed)
- Men or women, age 22 - 70, out-patient
- Participants who meet the DSM-5 clinical diagnostic criteria, in the opinion of the treating clinician, for primary diagnosis of unipolar, non-psychotic MDD. The intended treatment plan uses the labeled treatment parameters for TMS as described in the NeuroStar® System
- Women of child bearing potential must be using a medically accepted reliable means of contraception (for oral contraceptive medication: must be in use for at least 3 months)
- Women of childbearing potential must have a negative pregnancy test at screening using urine dipstick
- Participants must have the capacity to consent to all tests and examinations required by the protocol and must sign a written informed consent document to participate in the study.
Key exclusion criteria (7 listed)
- History of seizures or increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure or history of significant head trauma with loss of consciousness for ≥ 5 minutes
- Inability to locate and quantify a motor threshold as defined in the protocol
- Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the participant's head within 30 cm of the treatment coil excluding the mouth that cannot safely be removed. Examples include: cochlear implants; implanted electrodes/stimulators; aneurysm clips or coils; stents; bullet fragments; jewelry; and hair barrettes
- Any psychiatric disorder which, in the judgement of the Investigator, may hinder the participant from completing the procedures required by the study protocol
- Active or inactive implants (including device leads), including deep brain stimulators, and vagus nerve stimulators
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 |
|---|---|---|
| Transcranial Magnetic StimulatorAlso: TMS Therapy, NeurostarTranscranial magnetic stimulation (TMS) uses a targeted pulsed magnetic field, similar to what is used in an MRI (magnetic resonance imaging) machine. While the patient is awake and alert, NeuroStar TMS Therapy stimulates areas of the brain that are underactive in depression. | Device | Major Depressive Disorder |
Primary outcome
Clinical Global Impression - Severity Scale
Time frame: Baseline, 6 weeks, 3, 6, 9, and 12 months
The change from baseline to endpoint on the total score for the Clinical Global Impression - Severity scale will be reported for the 6 week 3, 6, 9, and 12 month time points. The 7-point scale requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The scale ranges from 1-7, where a higher score means a worse outcome.
5 secondary outcomes
Patient Health Questionnaire - 9-item Self Report
Time frame: Baseline, 6 weeks, 3, 6, 9, and 12 months
Inventory of Depressive Symptomatology - Self Report (IDS-SR)
Time frame: Baseline, 6 weeks, 3, 6, 9, and 12 months
EuroQol 5 Dimensions
Time frame: Baseline, 6 weeks, 3, 6, 9, and 12 months
Health Resource Utilization Questionnaire (HRU)
Time frame: Baseline, 6 weeks, 3, 6, 9, and 12 months
Short Form 36-item Questionnaire
Time frame: Baseline, 6 weeks, 3, 6, 9, and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- 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.
Mohamed Abdelghani, MBBCh, MSc, MRCPsych principal investigator
St. Pancras Hospital
1 site 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, run by Neuronetics at 1 site in United Kingdom.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical Global Impression - Severity Scale (time frame: Baseline, 6 weeks, 3, 6, 9, and 12 months). 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 8 Oct 2021.