Treatment of Major Depressive Disorder in the UK Using TMS Therapy

Sponsor

Neuronetics (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04217837

Collaborator

(none)

Enrollment

Location

23.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Device: Transcranial Magnetic Stimulator

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

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Transcranial Magnetic Stimulator 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. Other Names: TMS Therapy Neurostar

Arm

Intervention/Treatment

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.

Device: Transcranial Magnetic Stimulator

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.

Other Names:

TMS Therapy

Neurostar

Outcome Measures

Primary Outcome Measures

Clinical Global Impression - Severity Scale [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.

Secondary Outcome Measures

Patient Health Questionnaire - 9-item Self Report [Baseline, 6 weeks, 3, 6, 9, and 12 months]
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.
Inventory of Depressive Symptomatology - Self Report (IDS-SR) [Baseline, 6 weeks, 3, 6, 9, and 12 months]
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.
EuroQol 5 Dimensions [Baseline, 6 weeks, 3, 6, 9, and 12 months]
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.
Health Resource Utilization Questionnaire (HRU) [Baseline, 6 weeks, 3, 6, 9, and 12 months]
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.
Short Form 36-item Questionnaire [Baseline, 6 weeks, 3, 6, 9, and 12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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