Treatment of Major Depressive Disorder in the UK Using TMS Therapy

Neuronetics

Status: Withdrawn

Conditions: Major Depressive Disorder

Treatments: Device: Transcranial Magnetic Stimulator

Study type: Observational

Funder types: Other

Identifiers

NCT04217837

44-50011-000

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 22 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Major Depressive Disorder

Description:

Participants who meet the DSM-5 clinical diagnostic criteria, in the opinion of the treating clinician, for primary diagnosis of unipolar, non-psychotic MDD.

Treatment:

Device: Transcranial Magnetic Stimulator