Status:
COMPLETED
A Double-blind Sham Controlled Trial of rTMS in Treatment Resistant Major Depression
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The main treatment option for Treatment Resistant Depression is electroconvulsive therapy (ECT) which is often effective but complicated by cognitive side effects, need for anaesthesia and considerabl...
Detailed Description
Justification for project TRD is clearly a major health issue - depression is common, results in marked morbidity and mortality and a large percentage of patients do not respond to, or cannot tolerat...
Eligibility Criteria
Inclusion
- Patients will be included if they:
- Have a DSM-IV diagnosis of a major depressive episode (SCID 11).
- Aged 18-85.
- Have treatment resistant depression at Stage II of the Thase and Rush classification \[31\]; .e. have failed to achieve a clinical response, or did not tolerate, at least two separate antidepressant trials of sufficient dose for at least 6 weeks.
- Have a Hamilton Depression Rating Scale Score of \> 20 (moderate - severe depression). Including only a severely ill group of subjects limits the placebo response rate \[32\]. Moreover, this will allow us to address the application of rTMS methods in the most clinically relevant subgroup of patients (in addition helping to constrain group heterogeneity, a major issue in depression research).
- Have had no increase or initiation of new antidepressant (or other psychoactive) therapy in the 4 weeks prior to screening.
Exclusion
- Patients who have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating.
- In the opinion of the investigator, are a sufficient suicidal risk to require immediate electro-convulsive therapy.
- Have a current DSM IV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder (SCID II) or another axis 1 disorder.
- Please note: several of these criteria (e.g. inclusion criteria 1 \& 2, exclusion criteria 3) have been selected to explicitly constrain the heterogeneity of the sample to increase the likely power of the study to detect differences between the groups given the potentially subtle difference between the treatment methods.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00402220
Start Date
March 1 2007
End Date
January 1 2011
Last Update
October 19 2020
Active Locations (1)
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1
Alfred Psychiatry Research Centre
Prahran, Victoria, Australia, 3181