rTMS in the Treatment of Bipolar Depression - Full Text View

Sponsored by:	Bayside Health
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00436020

Purpose

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.

Condition	Intervention	Phase
Bipolar Affective Disorder	Device: TMS Device: Sham TMS	Phase II

MedlinePlus related topics: Bipolar Disorder Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	A Double-Blind Sham Controlled Trial of rTMS in the Treatment of Bipolar Depression

Further study details as provided by Bayside Health:

Primary Outcome Measures:

HAMD [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Active	Device: TMS Transcranial Magnetic Stimulation
2: Placebo Comparator Sham TMS	Device: Sham TMS Sham Transcranial Magnetic Stimulation

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436020

Contacts

Contact: Paul B Fitzgerald, MBBS, MPM, FRANCZP,PhD

+61 03 90766564 ext 66564

p.fitzgerald@alfred.org.au

Locations

Australia, Victoria
Alfred Psychiatry Research Centre	Recruiting
Prahran, Melbourne, Victoria, Australia, 3181
Principal Investigator: Paul B Fitzgerald, FRANZCP,PhD

Sponsors and Collaborators

Bayside Health

Investigators

Principal Investigator:

Paul B Fitzgerald, FRANZCP, PhD

Alfred Psychiatry Research Centre

More Information

Responsible Party:	Alfred Psychiatry Research Centre ( Professor Paul Fitzgerald )
Study ID Numbers:	paulfitzgerald
Study First Received:	February 14, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00436020
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:

clinical trial
TMS
depression
bipolar disorder

Study placed in the following topic categories:

Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 15, 2009