Status:
COMPLETED
rTMS in the Treatment of Bipolar Depression
Lead Sponsor:
Bayside Health
Conditions:
Bipolar Affective Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Bipolar affective disorder (BPAD) is: * A serious mental illness * Estimated to be present in as high as 6.4% of the population in Western populations * Associated with considerable disability and hi...
Detailed Description
Bipolar affective disorder is a serious mental illness with significant mortality and morbidity \[1\]. Some estimates of prevalence in Western populations are as high as 6.4% \[2\]. The depressive asp...
Eligibility Criteria
Inclusion
- Patients will be included if they:
- Have a DSM-IV diagnosis of a bipolar disorder (type I or II) and currently meet criteria for a major depressive episode (SCID 11).
- Be aged 18-70.
- Have the persistence of depressive symptoms for at least one month at sufficient severity to warrant a diagnosis of major depressive episode
- Have a Hamilton Depression Rating Scale Score of \> 20 (moderate - severe depression). Including only a more 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 :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00436020
Start Date
November 1 2007
End Date
June 1 2015
Last Update
October 19 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Alfred Psychiatry Research Centre
Prahran, Victoria, Australia, 3181