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Priming rTMS In Major Depression

A Randomised Double-Blind Trial of Low and High Frequency Stimulation rTMS (Repetitive Transcranial Magnetic Stimulation) In Major Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00168272
Enrollment
100
Registered
2005-09-15
Start date
2004-06-30
Completion date
2007-03-31
Last updated
2007-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Transcranial Magnetic Stimulation, Depression

Brief summary

The purpose of this study is to assist in understanding the most effective parameters for TMS in Depressive Disorders. Most research conducted has used high frequency stimulation on the left hemisphere.However, low frequency on the right hemisphere has also been shown to have antidepressant properties and appears to be better tolerated. A promising approach to improve responses to rTMS may be to combine high and low frequency stimulation where they are both applied to the right side of the brain. In this approach, high frequency stimulation is provided first which may 'prime' or pre-prepare the brain for low frequency stimulation in a way that enhances its response. Participants are randomised to receive active or placebo priming stimulation.If participants do not respond to this treatment condition after 10 sessions applied over a two week period they will be offered 10 session of high frequency left sided TMS treatment. Alternatively, if participants respond favorably they may continue with that treatment condition for another 10 sessions.

Detailed description

The primary outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis. At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as a MADRS score of less than or equal to 10. Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale), CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global Impression Scale), GAF (Global Assessment of Functioning Scale). A cognitive battery is also administered. Inclusion Criteria: * Moderate to severe depressive symptoms as indicated as MADRS \>20 * Failure to respond to a minimum of two antidepressant medications * No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial Exclusion Criteria * Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating * Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker * In the opinion of the investigator, are a sufficient suicide risk to require immediate electro-convulsive therapy * Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder

Interventions

DEVICETranscranial Magnetic Stimulation

Sponsors

The Alfred
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Moderate to severe depressive symptoms as indicated as MADRS \>20 * Failure to respond to a minimum of two antidepressant medications * No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial

Exclusion criteria

* Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating * Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker * In the opinion of the investigator, are a sufficient suicide risk to require immediate electro-convulsive therapy * Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder

Design outcomes

Primary

MeasureTime frame
The primary outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as less or equal to 10.

Secondary

MeasureTime frame
Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale), CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global Impression Scale), GAF (Global Assessment of Functioning Scale).

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026