Bipolar Disorder I

A Study to Evaluate the Effectiveness and Safety of BHV-7000 for Manic Episodes Associated with Bipolar I Disorder

Study Medication

BHV-7000 is a compound that increases potassium channel activation. Over the past several decades, these potassium channels have been discovered as a major part of the brain’s ability to regulate electrical activity. Importantly, these channels have been demonstrated to normalize hyperactive electrical activity in the brain, as an inherent mechanism of resilience. When their activity increases, so does resilience to symptoms seen in mood disorders, which we believe may translate to treating bipolar disorder.

In addition to this resilience-based mechanism, BHV-7000 works through pathways that overlap with commonly used mood stabilizers in bipolar disorder, such as lithium and lamotrigine. Importantly, we do not expect BHV-7000 to exhibit the side effects that often make other bipolar disorder treatments so difficult to tolerate. In contrast with similar potassium channel activating drugs, BHV-7000 is more specific to potassium channels, avoiding channels like GABA-A, which may translate to it being better tolerated. We hope to study this entirely new mechanism in bipolar disorder, with the hopes of bringing forward a medication without the side effects patients too often have to deal with.

Administration of the Study Medication

BHV-7000, or placebo, will be administered once a day via tablet .

The study will be conducted in an inpatient study facility, where participants will be treated for 3 weeks.