Bipolar disorder is a complex mental health condition that causes extreme mood swings, including emotional highs (mania or hypomania) and lows (depression). While many individuals manage the condition through medication and therapy, ongoing clinical trials play a critical role in exploring innovative treatments and improving the quality of life for those affected. This article delves into clinical trials for bipolar disorder in the United States, providing insights into how they work, their benefits, and the current studies underway.
Understanding Clinical Trials for Bipolar Disorder
Clinical trials are research studies designed to test the safety, efficacy, and potential side effects of new treatments, therapies, or interventions. For bipolar disorder, these trials often focus on:
- Developing new medications or optimizing existing ones.
- Exploring alternative therapies, such as neuromodulation or lifestyle interventions.
Why Participate in a Clinical Trial for Bipolar Disorder?
- Access to New Treatments: Participants may gain early access to innovative therapies not yet available to the public.
- Personalized Care: Clinical trials provide close monitoring and comprehensive medical attention from researchers and healthcare professionals.
- Advancing Science: By joining a trial, individuals contribute to research that could improve treatment options for millions of people with bipolar disorder.
- Compensation: Many trials offer financial compensation for time, travel, and related expenses.
It’s important to weigh the benefits against potential risks, such as side effects from experimental treatments or the possibility of receiving a placebo.
List Of Clinical Trials For Bipolar Treatment
Clinical Trials.Gov allows you to search for clinical trials for Bipolar Disorder
mHealth Estimate-based Algorithms Signaling Upcoming Recurrence of Episodes in Bipolar Disorders
Veterans with bipolar disorders (BD) experience recurrent and seemingly unpredictable periods of severe impairments in psychosocial functioning, such as participation in social roles and activities. Many effective treatments for BD emphasize early detection of bipolar episodes, in order to make necessary treatment adjustments and prevent psychosocial impairments associated with acute mood episodes. Unfortunately, acute mood episodes in BD are also associated with a decrease in a patient's insight into their own symptoms, which can prevent one's ability to self-report first signs of symptoms and functional declines. Moreover, routine care visits for BD are typically too infrequent to capture and effectively monitor day-to-day changes in a patient's mood and functioning.
Objective, low-effort, and continuous methods of tracking symptoms and social participation of Veterans with BD in real-time and in-situ are needed to provide early (i.e., days in advance) warning signs of acute bipolar episodes and functional declines, which in turn would enable well-timed interventions to prevent poor psychosocial outcomes. mHealth refers to the use of mobile and wireless devices as part of patient care and offers many potential opportunities for early detection of and intervention for acute mood states in this population. However, these mHealth approaches have not been investigated in Veterans with BD. In a Small Projects in Rehabilitation Research (SPiRE)-funded pilot study, the investigator team established high feasibility and acceptability of one such innovative passive mHealth approach using a smartphone program, or an app, in a small sample of Veterans with BD to track their smartphone's GPS/location. The pilot study used a priori location context ratings of visited places (e.g., a priori ratings on types of activities usually engaged in at a frequently visited location) to derive unobtrusive measures of social participation (e.g., time spent at work-related locations). The goal of this Merit Review proposal is to establish reliable and valid machine-learning algorithms using the same types of mHealth data to prospectively (days in advance) detect declines in social participation and prospective onset of mania and depression in Veterans with BD. This proposal has three aims:
Aim 1. To establish a machine learning algorithm using GPS/location data for predicting prospective declines in social participation in Veterans with BD.
Aim 2. To establish machine learning algorithms using GPS/location data for predicting prospective acute BD clinical states. The investigators will explore whether adding more burdensome daily self-report and voice diaries' speech analysis features improves the models' precision using statistical indices of prediction precision or accuracy.
Aim 3. To explore clinical implementation of the mHealth-based algorithms in treatment of BD. Focus groups of VA providers and administrators will assess feasibility of algorithms' implementation in clinical care.
Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if transcranial magnetic stimulation (TMS) can help improve emotion regulation for individuals with bipolar mood disorders.Detailed DescriptionThe objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to ventrolateral prefrontal cortex (VLPFC) or inferior parietal lobule (IPL) can improve performance on emotion regulation tasks in patients with bipolar disorder. Results from this study will help inform future treatment development to improve emotion regulation in patients with bipolar disorder. The study will proceed in two phases: During Phase 1, a cohort of 30 healthy control subjects will be recruited in order to establish a normative sample from which to compare patient data. Functional magnetic resonance imaging (fMRI) data will be collected from healthy control participants during performance on two emotion regulation tasks (probing implicit and explicit emotion regulation). Data from these subjects will provide a normative distribution of VLPFC and IPL function from which to compare individual patients. During Phase 2, a cohort of 30 patients diagnosed with bipolar disorder will be recruited. Patient participants will perform the same two emotion regulation tasks during fMRI scanning. Data from individual patients will be analyzed to detect specific VLPFC and IPL subregions showing activation deviations from healthy controls (Phase 1 data). Patient-specific VLPFC and IPL subregions showing patterns of activation greater than two standard deviations from healthy controls will be used as individualized target sites for TMS stimulation. Patients will then receive high-dose iTBS-TMS (1800 pulses) of the VLPFC and IPL, and sham iTBS-TMS to the dorsomedial prefrontal cortex (dmPFC) across three separate study visits. Order of target stimulation will be randomized across participants. TMS sessions will take approximately 10 minutes and will be immediately followed by an fMRI scanning session, during which participants will again complete the implicit and explicit emotion regulation tasks. TMS sessions will take place in the scanning bay to enable quick transition to the fMRI task. Baseline scanning sessions and either active TMS-fMRI or sham TMS-fMRI sessions will occur on separate days, no more than two weeks apart. Effects of iTBS-TMS on emotion regulation will be evaluated by comparing pre-TMS versus post-TMS behavior, neural activation, and functional connectivity patterns during performance on implicit and explicit emotion regulation tasks.
BHV-7000 Acute Treatment of Bipolar Mania
The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.Official TitleA Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
Eligibility for Bipolar Clinical Trials
Each clinical trial has specific criteria for participation to ensure the safety of volunteers and the reliability of the study. Common eligibility factors include:
- Diagnosis: Participants must have a confirmed diagnosis of bipolar disorder, which may include Bipolar I, Bipolar II, or cyclothymic disorder.
- Age: Most trials require participants to be over 18, though some include adolescents or older adults.
- Symptom Severity: Trials may target specific symptoms, such as mania, depression, or treatment-resistant cases.
- Previous Treatment History: Some studies focus on individuals who have tried standard treatments without success, while others may recruit those new to treatment.
- General Health: Participants must meet certain health criteria, which may involve physical and mental health assessments.
What to Expect During a Clinical Trial
Participating in a clinical trial involves several stages:
- Screening: Researchers conduct evaluations to ensure participants meet eligibility criteria.
- Informed Consent: Participants receive detailed information about the study, including its purpose, risks, and benefits.
- Study Phases:
- Baseline Assessment: Data on current symptoms and medical history is collected.
- Treatment Phase: Participants receive the assigned intervention (e.g., medication or therapy).
- Follow-Up: After completing the trial, participants undergo assessments to evaluate long-term effects.
- Safety Monitoring: Researchers closely monitor participants to manage side effects or complications.
Benefits of Clinical Trials for Bipolar Treatment
Clinical trials offer a unique opportunity to advance mental health care. Benefits include:
- Innovation: Trials lead to the development of more effective and personalized treatments.
- Access: Participants may benefit from therapies not yet available to the public.
- Awareness: Joining a trial helps raise awareness and understanding of bipolar disorder.
Conclusion
Clinical trials for bipolar disorder in the U.S. are essential for improving treatment options and enhancing the lives of those affected by this condition. Whether you’re seeking new therapies or want to contribute to the future of mental health care, participating in a trial is a valuable step. Consult with your healthcare provider and explore resources like ClinicalTrials.gov to find the right trial for you. Together, we can work toward better outcomes and hope for everyone living with bipolar disorder.
