rTMS in the Treatment of Bipolar Depression

NCT00436020 | Completed

• 1 other identifier: paulfitzgerald
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Affective Disorder

Keywords

clinical trial; TMS; depression; bipolar disorder

Outcome Measures

Primary Outcomes (1)

• HAMD

  4 weeks and 8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Active

Device: TMS

2

PLACEBO COMPARATOR

Sham TMS

Device: Sham TMS

Interventions

TMS DEVICE

Transcranial Magnetic Stimulation

1

Sham TMS DEVICE

Sham Transcranial Magnetic Stimulation

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

Alfred Psychiatry Research Centre

Prahran, Victoria, 3181, Australia

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Paul B Fitzgerald, FRANZCP, PhD

  Alfred Psychiatry Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2007
• First Posted: February 16, 2007
• Study Start: November 1, 2007
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

AU (1)