New Hope for Depression Sufferers in Charleston

Coastal Carolina Research Center in North Charleston is one of approximately 70 research sites across the United States participating in a Phase 2 clinical trial aimed at addressing major depressive disorder (MDD). This study will evaluate the safety and efficacy of BHV-7000, a novel investigational medication developed to meet the critical need for better-tolerated and more effective options for individuals living with MDD. For more information about the trial and how to participate, visit MDDclinicalstudy.com.

MDD is a prevalent and serious mood disorder affecting over 21 million adults in the United States.1 This condition often leads to profound sadness, loss of interest in activities, and disruptions in daily life. Around one-third of people with MDD are resistant to current antidepressant therapies, highlighting the urgent need for new approaches.2

BHV-7000 targets potassium channels in the brain, which help regulate electrical activity. This novel mechanism is designed to stabilize overactive brain activity that contributes to depression.3 Early clinical research has shown evidence of antidepressant activity and suggests that BHV-7000 may be better tolerated than existing options without the typical side effects of antidepressant medications like sexual dysfunction, irritability, and emotional blunting.

“MDD is notoriously challenging to manage due to the resistance many patients experience with existing therapies and the significant side effects associated with current medications,” said Dr. Paul Robbins, the study's primary investigator at Coastal Carolina Research Center. “Research like this is essential for identifying new solutions. BHV-7000 has shown potential in early studies for better tolerability and effectiveness, for those who struggle with this debilitating disorder.”

Understanding Major Depressive Disorder

MDD is more than occasional sadness; it’s a complex mood disorder characterized by symptoms such as:4

• Recurrent episodes of profound sadness
• Loss of interest or pleasure
• Changes in appetite or weight
• Sleep disturbances
• Fatigue
• Feelings of worthlessness or guilt
• Difficulty concentrating or making decisions

For many individuals, these episodes can last for weeks or months, significantly impacting their ability to function in daily life. Worldwide, MDD remains a leading cause of disability, affecting mood, cognition, and behavior while increasing the risk of suicide.5

Details of the Clinical Trial

This Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of BHV-7000 in individuals with MDD. Participants must be between 18 and 75 years old, have a diagnosis of MDD, and be experiencing a moderate to severe depressive episode lasting at least two months. Those enrolled will take BHV-7000 or a placebo via tablet for up to 12 weeks, with seven study visits during this period. Participants may be eligible to continue treatment in a separate extension study.

Participation in this study represents an opportunity to contribute to advancing research that could change the landscape of MDD therapies.

How to Get Involved

If you or someone you know is interested in participating in the study or would like more information about eligibility criteria and study locations, visit MDDclinicalstudy.com.

References

1. National Institute of Mental Health. Major Depression. Available at: https://www.nimh.nih.gov/health/statistics/major-depression. Accessed December 12, 2024.

2. Voineskos D, Daskalakis Z, Blumberger DM. Management of Treatment-Resistant Depression: Challenges and Strategies: Neuropsychiatr Dis Treat. 2020; 16: 221-234.

3. Costi S, Morris LS, Kirkwood KA, et al. Impact of the KCNQ2/3 Channel Opener Ezogabine on Reward Circuit Activity and Clinical Symptoms in Depression: Results From a Randomized Controlled Trial. Am J Psychiatry. 2021 May 1;178(5):437-446.

4. Cleveland Clinic. Clinical Depression (Major Depressive Disorder). Available at https://my.clevelandclinic.org/health/diseases/24481-clinical-depression-major-depressive-disorder. Accessed December 12, 2024.

5. Kamran M, Bibi F, Rehman A, et al. Major Depressive Disorder: Existing Hypotheses about Pathophysiological Mechanisms and New Genetic Findings. Genes (Basel). 2022 Apr; 13(4): 646.

Content Source: Biohaven, Ltd.