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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00436020




Registration number
NCT00436020
Ethics application status
Date submitted
14/02/2007
Date registered
16/02/2007
Date last updated
9/05/2008

Titles & IDs
Public title
rTMS in the Treatment of Bipolar Depression
Scientific title
A Double-Blind Sham Controlled Trial of rTMS in the Treatment of Bipolar Depression
Secondary ID [1] 0 0
paulfitzgerald
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Affective Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Other mental health disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - TMS
Treatment: Devices - Sham TMS

Active Comparator: 1 - Active

Placebo Comparator: 2 - Sham TMS


Treatment: Devices: TMS
Transcranial Magnetic Stimulation

Treatment: Devices: Sham TMS
Sham Transcranial Magnetic Stimulation

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HAMD
Timepoint [1] 0 0
4 weeks and 8 weeks

Eligibility
Key inclusion criteria
Patients will be included if they:

1. Have a DSM-IV diagnosis of a bipolar disorder (type I or II) and currently meet
criteria for a major depressive episode (SCID 11).

2. Be aged 18-70.

3. Have the persistence of depressive symptoms for at least one month at sufficient
severity to warrant a diagnosis of major depressive episode

4. 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).

5. Have had no increase or initiation of new antidepressant (or other psychoactive)
therapy in the 4 weeks prior to screening.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have an unstable medical condition, neurological disorder or any history
of a seizure disorder or are currently pregnant or lactating.

2. In the opinion of the investigator, are a sufficient suicidal risk to require
immediate electro-convulsive therapy.

3. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Psychiatry Research Centre - Prahran, Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Prahran, Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
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 high morbidity.

- Characterized by periods of both lowered and elevated mood (i.e. depression and
mania/hypomania respectively).

The depressive aspect of bipolar disorder is often overlooked, possibly due to its less
dramatic nature, despite its significant impact on the lives of those affected. Bipolar
depression (BPAD-DP) is associated with a twenty fold increased risk of suicide, and
typically lasts three to five times as long as a manic or hypomanic episode. Despite this,
there has been relatively sparse investigation of treatments for BPAD-DP, with guidelines
based primarily on expert judgment rather than clinical trials. In addition a significant
proportion of patients with bipolar depression do not respond to the range of commonly used
medications. One of the only substantially new treatments developed for unipolar depression
in recent years has been the advent of repetitive transcranial magnetic stimulation (rTMS).
Repetitive TMS has been evaluated in over 20 trials conducted over the last ten years, but no
substantive trials have explored its use in bipolar depression. We propose to do this,
conducting a large scale clinical trial. The trial will include the assessment of both high
frequency left sided rTMS (as there is clearly the greatest evidence for the effectiveness of
this in unipolar depression) and low frequency right sided rTMS (as this there is growing
evidence of the effectiveness of this in unipolar depression and we have an excellent pilot
study to suggest its potential in BPAD-DP and it has never previously been assessed in a
clinical trial exclusively targeting this patient group). Our previous research strongly
supports the effectiveness of rTMS paradigms including low frequency right-sided stimulation
in unipolar depression and suggests these may have value in BPAD-DP. As BPAD-DP is clearly a
clinical problem of significant impact and with limited treatment options, there is a
pressing need for the development and definitive testing of novel treatments such as rTMS.
Trial website
https://clinicaltrials.gov/show/NCT00436020
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul B Fitzgerald, FRANZCP, PhD
Address 0 0
Alfred Psychiatry Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul B Fitzgerald, MBBS, MPM, FRANCZP,PhD
Address 0 0
Country 0 0
Phone 0 0
+61 03 90766564
Fax 0 0
Email 0 0
p.fitzgerald@alfred.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00436020