Treatment of Major Depressive Disorder in the UK Using TMS Therapy

NCT04217837 | Withdrawn DMC FDA Device

• 1 other identifier: 44-50011-000
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Transcranial Magnetic Stimulation; Major Depressive Disorder; MDD; TMS; NeuroStar Advanced Therapy System; Repetitive Transcranial Magnetic Stimulation; rTMS

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 weeks, 3, 6, 9, and 12 months

Secondary Outcomes (5)

• Patient Health Questionnaire - 9-item Self Report

  Baseline, 6 weeks, 3, 6, 9, and 12 months

• Inventory of Depressive Symptomatology - Self Report (IDS-SR)

  Baseline, 6 weeks, 3, 6, 9, and 12 months

• EuroQol 5 Dimensions

  Baseline, 6 weeks, 3, 6, 9, and 12 months

• Health Resource Utilization Questionnaire (HRU)

  Baseline, 6 weeks, 3, 6, 9, and 12 months

• Short Form 36-item Questionnaire

  Baseline, 6 weeks, 3, 6, 9, and 12 months

Study Arms (1)

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

Interventions

Transcranial Magnetic Stimulator DEVICE

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.

Also known as: TMS Therapy, Neurostar

Major Depressive Disorder

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical Practice

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuronetics: lead

Study Sites (1)

St Pancras Hospital

London, NW1 0PE, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Mohamed Abdelghani, MBBCh, MSc, MRCPsych

  St. Pancras Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 3, 2020
• Study Start: March 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: October 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)