rTMS in the Treatment of Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00436020
Recruitment Status : Unknown
Verified May 2008 by Bayside Health.
Recruitment status was:  Recruiting
First Posted : February 16, 2007
Last Update Posted : May 9, 2008
Information provided by:
Bayside Health

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.

Condition or disease Intervention/treatment Phase
Bipolar Affective Disorder Device: TMS Device: Sham TMS Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Sham Controlled Trial of rTMS in the Treatment of Bipolar Depression
Study Start Date : April 2007
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Device: TMS
Transcranial Magnetic Stimulation
Placebo Comparator: 2
Sham TMS
Device: Sham TMS
Sham Transcranial Magnetic Stimulation

Primary Outcome Measures :
  1. HAMD [ Time Frame: 4 weeks and 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00436020

Contact: Paul B Fitzgerald, MBBS, MPM, FRANCZP,PhD +61 03 90766564 ext 66564

Australia, Victoria
Alfred Psychiatry Research Centre Recruiting
Prahran, Melbourne, Victoria, Australia, 3181
Principal Investigator: Paul B Fitzgerald, FRANZCP,PhD         
Sponsors and Collaborators
Bayside Health
Principal Investigator: Paul B Fitzgerald, FRANZCP, PhD Alfred Psychiatry Research Centre

Responsible Party: Professor Paul Fitzgerald, Alfred Psychiatry Research Centre Identifier: NCT00436020     History of Changes
Other Study ID Numbers: paulfitzgerald
First Posted: February 16, 2007    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008

Keywords provided by Bayside Health:
clinical trial
bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Mood Disorders
Genetic Diseases, X-Linked
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Genetic Diseases, Inborn