What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder, such as transcranial magnetic stimulation (TMS) and its variants like accelerated intermittent theta-burst stimulation (aiTBS), generally have mild side effects including headaches, scalp discomfort, and tingling sensations. Pharmacological treatments, such as lithium, anticonvulsants, and antipsychotics, can have more significant side effects. Lithium may cause weight gain, tremors, and thyroid dysfunction. Anticonvulsants like valproate can lead to gastrointestinal issues and liver toxicity, while antipsychotics may cause sedation, weight gain, and metabolic syndrome. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Bipolar Disorder, including mood stabilizers like lithium, anticonvulsants such as valproate and lamotrigine, and atypical antipsychotics like quetiapine, aripiprazole, and olanzapine. While repetitive transcranial magnetic stimulation (rTMS) has been explored for its potential benefits in bipolar disorder, particularly for depressive episodes, it is not yet FDA-approved specifically for bipolar disorder. The aiTBS trial aims to investigate a similar neuromodulation approach, targeting the left dorsolateral prefrontal cortex to induce antidepressant effects in treatment-resistant bipolar II depression.

What other types of research exist?

Promising alternatives to aiTBS for Bipolar Disorder patients include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which has shown efficacy in reducing depressive symptoms and can be used as a maintenance treatment. 2) Transcranial Direct Current Stimulation (tDCS), which has demonstrated mood-elevating effects and cognitive benefits. 3) Vagus Nerve Stimulation (VNS), which has been effective in treatment-resistant cases and shows long-term benefits. 4) Electroconvulsive Therapy (ECT), which remains a highly effective option for severe cases, particularly when rapid symptom relief is needed.

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Behavioural Intervention

aiTBS for Depression

N/A

Recruiting

Led By Nolan Williams, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and immediate post-treatment, 1-month

Summary

This trial investigates whether aiTBS, a type of brain stimulation using magnetic fields, can help people with bipolar II disorder who haven't responded to other treatments. The treatment targets a specific brain area to improve mood and reduce depression. Accelerated intermittent theta burst stimulation (aiTBS) is a noninvasive neurostimulation technique that shows promise for improving clinical outcomes in treatment-resistant depression.

Who is the study for?

This trial is for adults aged 18-80 with bipolar II disorder currently experiencing a major depressive episode, who haven't responded to standard treatments. They must be in good health, not have hypomania or psychosis, and women must use effective contraception. Excluded are those with metal in their head, pacemakers, substance abuse issues, severe insomnia, certain mental health conditions like anxiety disorders or personality disorders, recent suicidal behavior or thoughts.

What is being tested?

The study tests accelerated intermittent theta-burst stimulation (aiTBS) targeting the left dorsolateral prefrontal cortex to treat treatment-resistant depression in bipolar II disorder patients. It's a double-blind trial comparing active aiTBS against sham (placebo) aiTBS using the MagPro rTMS system.

What are the potential side effects?

While specific side effects of aiTBS aren't detailed here, similar treatments can cause discomfort at the stimulation site on the scalp, headache or lightheadedness immediately after treatment. There may also be a risk of seizure although it's considered rare.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and immediate post-treatment, 1-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and immediate post-treatment, 1-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and immediate post-treatment, 1-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)

Secondary study objectives

Change from baseline Young Mania Rating Scale (YMRS)

Change in resting-state functional connectivity

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active aiTBSActive Control1 Intervention

Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.

Group II: Sham aiTBSPlacebo Group1 Intervention

Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bipolar Disorder include neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS) and transcranial direct-current stimulation (tDCS), which modulate neuronal activity in the prefrontal cortex to alleviate depressive and manic symptoms. For instance, aiTBS targets the left dorsolateral prefrontal cortex to induce anti-depressant effects by altering neural circuits involved in mood regulation. Pharmacological treatments, such as mood stabilizers (e.g., lithium) and antipsychotics, work by balancing neurotransmitter levels to stabilize mood swings. Understanding these mechanisms is crucial for patients as it helps tailor treatments to their specific neural and biochemical imbalances, potentially improving outcomes and reducing side effects.