A Comparative Trial of TMS Approaches to Treating Depression

Phase 4

Withdrawn

• Conditions: Depression
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT01906905
• Lead Sponsor: The University of New South Wales

Brief Summary

Trancranial Magnetic Stimulation (TMS) is a non-drug and non-invasive treatment for depression and has been investigated for the treatment of psychiatric illness for over 15 years. There is now established evidence indicating TMS is an effective treatment for depression. However, the effectiveness of TMS varies between people, thus requiring further research to investigate its optimal application. Investigators want to compare the effectiveness of different forms of TMS, given with differing stimulation settings to the right or left side of the brain that has been associated with depression. This could potentially help clinicians in the future to improve the prescription of TMS as a treatment for depression.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-21
• Study First Posted: 2013-07-24
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

1. Age ≥18 years.
2. DSM-IV diagnosis of current Major Depressive Episode.
3. MADRS score of 20 or more.
4. Able to give informed consent.

Exclusion Criteria

1. DSM-IV psychotic disorder.
2. Drug or alcohol abuse or dependence (preceding 3 months).
3. Inadequate response to ECT (current episode of depression).
4. Rapid clinical response required, e.g. high suicide risk.
5. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
6. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
7. Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcranial Magnetic Stimulation	Transcranial Magnetic Stimulation	Active TMS (1)
Transcranial Magnetic Stimulation 2	Transcranial Magnetic Stimulation	Active TMS (2)
Transcranial Magnetic Stimulation 3	Transcranial Magnetic Stimulation	Active TMS (3)

Primary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale(MADRS)	Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.

Trial Locations

Locations (1)

Black Dog Institute, University of New South Wales; 🇦🇺 Sydney, New South Wales, Australia