Clinical trial NCT04217837: Treatment of Major Depressive Disorder in the UK Using TMS Therapy
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Major Depressive Disorder
Keywords: Transcranial Magnetic Stimulation
Major Depressive Disorder
MDD
TMS
NeuroStar Advanced Therapy System
Repetitive Transcranial Magnetic Stimulation
rTMS
Lead sponsor: Neuronetics
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical Practice

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Men or women, age 22 - 70, out-patient
2. 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
3. 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)
4. Women of childbearing potential must have a negative pregnancy test at screening using urine dipstick
5. 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:

1. 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
2. Inability to locate and quantify a motor threshold as defined in the protocol
3. 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
4. Any psychiatric disorder which, in the judgement of the Investigator, may hinder the participant from completing the procedures required by the study protocol
5. Active or inactive implants (including device leads), including deep brain stimulators, and vagus nerve stimulators
6. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease
7. Known or suspected pregnancy

Primary outcomes:
measure: Clinical Global Impression - Severity Scale
timeFrame: Baseline, 6 weeks, 3, 6, 9, and 12 months
Secondary outcomes:
measure: Patient Health Questionnaire - 9-item Self Report
timeFrame: Baseline, 6 weeks, 3, 6, 9, and 12 months
measure: Inventory of Depressive Symptomatology - Self Report (IDS-SR)
timeFrame: Baseline, 6 weeks, 3, 6, 9, and 12 months
measure: EuroQol 5 Dimensions
timeFrame: Baseline, 6 weeks, 3, 6, 9, and 12 months
measure: Health Resource Utilization Questionnaire (HRU)
timeFrame: Baseline, 6 weeks, 3, 6, 9, and 12 months
measure: Short Form 36-item Questionnaire
timeFrame: Baseline, 6 weeks, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Pancras Hospital
Study officials:
affiliation: St. Pancras Hospital
name: Mohamed Abdelghani, MBBCh, MSc, MRCPsych
role: PRINCIPAL_INVESTIGATOR
References: