Treatment of Major Depressive Disorder in the UK Using TMS Therapy

Withdrawn

• Conditions: Major Depressive Disorder
• Interventions: Device: Transcranial Magnetic Stimulator

• Registration Number: NCT04217837
• Lead Sponsor: Neuronetics

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.

Study Timeline

• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-03
• Study Start: 2020-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-08
• Primary Completion: 2022-02
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major Depressive Disorder	Transcranial Magnetic Stimulator	Participants who meet the DSM-5 clinical diagnostic criteria, in the opinion of the treating clinician, for primary diagnosis of unipolar, non-psychotic MDD.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

St Pancras Hospital; 🇬🇧 London, United Kingdom