Low Frequency rTMS for Bipolar Depression
(FLARE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment option for individuals with bipolar depression who haven't responded to other treatments. Participants will receive low-frequency rTMS (repetitive transcranial magnetic stimulation), a non-invasive brain stimulation, to determine its safety and effectiveness in reducing depression symptoms. The trial seeks individuals with bipolar disorder who are currently experiencing a depressive episode and have found little relief from other treatments. Participants should not be in a mixed or manic episode and must commit to the treatment schedule. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop taking my current medications for the trial?
The trial does not specify that you need to stop taking your current medications, but you must not have started or increased any psychotropic medications for depression in the 4 weeks before screening. You must also be on a specific mood stabilizer like lithium or quetiapine, and cannot be taking anticonvulsants or more than 2 mg of lorazepam daily.
What prior data suggests that this low frequency rTMS is safe for individuals with bipolar depression?
Research has shown that low-frequency repetitive transcranial magnetic stimulation (rTMS) on the right side of the front part of the brain is generally safe. Studies indicate it usually causes only mild side effects and does not harm brain function. This treatment has been tested on individuals with treatment-resistant depression, including teenagers, and has been well-tolerated. Some individuals might experience minor discomfort or irritation on the scalp, but serious side effects are rare. These findings suggest that this treatment is safe, although individual experiences can vary.12345
Why do researchers think this study treatment might be promising?
Most treatments for bipolar depression involve medications like mood stabilizers, antipsychotics, or antidepressants, which can take weeks to show effectiveness and may come with side effects. But low frequency rTMS (repetitive Transcranial Magnetic Stimulation) offers a different approach. This treatment targets the brain's right dorsolateral prefrontal cortex using magnetic fields to stimulate nerve cells. Researchers are excited because this non-invasive method could provide faster relief with fewer side effects, offering a promising alternative for those who haven't found success with traditional medications.
What evidence suggests that low frequency rTMS is effective for bipolar depression?
Studies have shown that low frequency repetitive transcranial magnetic stimulation (LFR rTMS) on a specific brain area can improve symptoms in people with bipolar depression unresponsive to other treatments. In this trial, participants will receive low frequency (1Hz) rTMS to the Right Dorsolateral Prefrontal Cortex. Research indicates that this method is as effective as other rTMS types targeting different brain areas. The treatment stimulates certain brain pathways, potentially improving mood. Some studies suggest it offers benefits similar to standard antidepressants, making it a promising option for those who haven't found relief with other treatments.12467
Who Is on the Research Team?
Tyler Kaster
Principal Investigator
CAMH
Are You a Good Fit for This Trial?
This trial is for individuals with treatment-resistant Bipolar Depression (BD-DE) who haven't improved after other therapies like iTBS or sham treatment. Participants should be able to attend daily sessions for 30 days and follow-ups.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 30 days of low frequency rTMS treatment for bipolar depression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS
Trial Overview
The study tests low frequency repetitive Transcranial Magnetic Stimulation (rTMS) on the right Dorsolateral Pre Frontal Cortex. It aims to see if this can help those with BD-DE when standard treatments fail, measuring depression and mania symptoms over time.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Individuals will all receive 30 treatments of low frequency (1Hz) rTMS delivered to the Right Dorsolateral Prefrontal Cortex. rTMS treatment will be delivered using the MagPro X100/R30 stimulator and use the Cool-B70 coil (MagVenture, Farum, Denmark), a figure 8 coil with active cooling.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tyler Kaster
Lead Sponsor
The Poul Hansen Family Centre for Depression
Collaborator
University Health Network (UHN)
Collaborator
Toronto Western Hospital, Canada
Collaborator
Citations
Low Frequency Right Dorsolateral Pre Frontal Cortical ...
This work will develop the evidence supporting the use of LFR rTMS for individuals with treatment-resistant BD-DE who currently have limited treatment options ...
Efficacy and safety of low-frequency repetitive transcranial ...
This study aims to examine the efficacy and safety of 1-Hz rTMS to the right prefrontal cortex of patients with treatment-resistant bipolar depression. rTMS for ...
Clinical effectiveness of switching to right lateral ...
Low frequency rTMS stimulation of the right frontal cortex is as effective as high frequency rTMS stimulation of the left frontal cortex for ...
Low frequency repetitive transcranial magnetic stimulation ...
These findings demonstrate that LF rTMS to the right DLPFC was able to stimulate the cortico-striato-thalamo-cortical pathway, which is ...
A Meta-Analysis of Randomized, Double-Blind and Sham ...
LF-rTMS is a promising treatment for MD, as it provides clinically meaningful benefits that are comparable to those of standard antidepressants and high- ...
Efficacy and safety of low-frequency repetitive transcranial ...
LF-rTMS is generally safe, with mild adverse effects and no negative impact on neurocognitive performance for adolescents with FE-MDD.
Low frequency repetitive transcranial magnetic stimulation to ...
Low-frequency rtms over right dorsolateral prefrontal cortex in the treatment of resistant depression: cognitive improvement is independent ...
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