BHV-7000 Acute Treatment of Bipolar Mania

Key Inclusion Criteria:

1. Participant must be voluntarily hospitalized for a current manic episode.

2. Male and female participants 18 years to 75 years of age at the time of thescreening visit.

3. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.

4. Meets DSM-5 criteria for bipolar disorder type I, with or without mixed features, asconfirmed by MINI interview with at least one well- defined prior mood episode (inaddition to the current episode). The most recent prior manic episode must haveoccurred in the last 2 years.

5. Episode of mania must not exceed 12 weeks in duration.

6. Participants must be able and willing to discontinue all other psychotropicmedications during the Screening Phase (e.g., antidepressant, antimanic,antipsychotic medications).

Key Exclusion Criteria:

1. Rapid cycling is excluded as defined herein by subjects who have experienced ≥ 6distinct mood episodes in a year. Consecutive mood episodes must be demarcatedeither by a partial or full remission of at least 2 months' duration or by a switchto an episode of opposite polarity. Each manic or mixed episode must have lasted atleast 1 week, and each hypomanic episode must have lasted at least 4 days.

2. Participants with a confirmed lifetime history of schizophrenia, psychoticdisorders, dementia, delirium, amnesia, neurodegenerative disease, traumatic braininjury with clinically significant sequalae, seizure disorder, or otherneurocognitive disorder. Previous diagnosis of psychotic spectrum disorders areallowable if the Investigator deems the diagnosis to be describing symptoms relatedto bipolar disorder.

3. Any medical condition, based on the judgement of the Investigator, that wouldconfound the ability to adequately assess safety and efficacy outcome measures.