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rTMS in the Treatment of Bipolar Depression

NCT00436020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-10-19

No results posted yet for this study

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.

Conditions

  • Bipolar Affective Disorder

Interventions

DEVICE

TMS

Transcranial Magnetic Stimulation

DEVICE

Sham TMS

Sham Transcranial Magnetic Stimulation

Sponsors & Collaborators

  • Bayside Health

    lead OTHER_GOV

Principal Investigators

  • Paul B Fitzgerald, FRANZCP, PhD · Alfred Psychiatry Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00436020 on ClinicalTrials.gov