rTMS in the Treatment of Bipolar Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00436020
First received: February 14, 2007
Last updated: May 5, 2008
Last verified: May 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Sham Controlled Trial of rTMS in the Treatment of Bipolar Depression

Resource links provided by NLM:


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
Active Comparator: 1
Active
Device: TMS
Transcranial Magnetic Stimulation
Placebo Comparator: 2
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:

  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Bayside Health:
clinical trial
TMS
depression
bipolar disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mood Disorders
Bipolar Disorder
Genetic Diseases, X-Linked
Behavioral Symptoms
Mental Disorders
Affective Disorders, Psychotic
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014