Investigating the effect of treatment dose on clinical response to Repetitive Transcranial Magnetic Stimulation (rTMS) in Major Depression.

Not Applicable

Completed

• Conditions: Mental Health - Depression; Treatment Resistant Major Depression

• Registration Number: ACTRN12612000321842
• Lead Sponsor: Professor Paul Fitzgerald

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-21
• Study Completion: 2015-10-30
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients with depression:
1. Have a DSM-IV diagnosis of a major depressive episode

2. Have failed to respond to adequate antidepressant medical therapy. This will be defined by at least two courses of antidepressant medication (from two medication classes) at therapeutic doses for a minimum of six weeks. Adequate daily dose will be considered to be a minimum of: 150mg of Imipramine or equivalent for tricyclic antidepressants, 20mg of Fluoxetine or equivalent for serotonin re-uptake inhibitors, 600mg of Moclobemide, 600mg of Nefazadone, 150mg of Venlafaxine, 60mg of Phenelzine or equivalent for monoamine oxidase inhibitors

3. Have a Hamilton Depression Rating Scale of > 16 (moderate – severe depression)

4. Have had no increase in, or initiation of new antidepressant therapy in the 4 weeks prior to screening.

Healthy controls for the scanning sub study:
1. No personal history of psychiatric illness as determined via clinical interview.

Exclusion Criteria

1. Have an unstable medical condition, neurological disorder or any history of a seizure disorder, or are currently pregnant or lactating

For depression participants only:
2. In the opinion of the investigator, are at sufficient risk of suicide to require immediate ECT

3. Have a current DSM-IV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another Axis 1 disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: change in severity of depressive symptoms, defined as:<br><br>Hamilton Depression Rating Scale (HAMD; 17 item version) - Clinical response defined as a reduction of at least 50% from baseline, clinical remission defined as a score <= 7[Baseline, and after every 5 treatments (weeks 1, 2, 3, 4)]

Secondary Outcome Measures

Name	Time	Method
Predictors of antidepressant response to TMS.<br><br>Specifically, we will explore the potential predictors of antidepressant response to rTMS using brain imaging analyses, and the use of tasks related to risk and reward decision making, in a subset of participants:<br><br>1. We will conduct an assessment of decision making related to reward with several computer based experimental tasks (eg. the Ultimatum Game, Signal Detection Task).<br><br>2. We will use the MRI data to model the differences between patients and controls in subcortical activation patterns induced by the decision making task, and model the relationship between activation and response to treatment using response and other relevant clinical variables in regression analyses.[Analysis of a series of scans obtained in the one scanning session. Analysis will occur at the end of the study once all data has been collected.]