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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.
Conditions:
🦠 Bipolar Disorder
🗓️ Study Start (Actual) 28 May 2024
🗓️ Primary Completion (Estimated) March 2025
✅ Study Completion (Estimated) April 2025
👥 Enrollment (Estimated) 256
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Bentonville, Arkansas, United States
📍 Little Rock, Arkansas, United States
📍 Rogers, Arkansas, United States
📍 Anaheim, California, United States
📍 Bellflower, California, United States
📍 Culver City, California, United States
📍 Garden Grove, California, United States
📍 Lemon Grove, California, United States
📍 Orange, California, United States
📍 Riverside, California, United States
📍 Torrance, California, United States
📍 Hollywood, Florida, United States
📍 Hollywood, Florida, United States
📍 Miami Lakes, Florida, United States
📍 Miami Lakes, Florida, United States
📍 Miami, Florida, United States
📍 West Palm Beach, Florida, United States
📍 Atlanta, Georgia, United States
📍 Decatur, Georgia, United States
📍 Savannah, Georgia, United States
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 Gaithersburg, Maryland, United States
📍 Flowood, Mississippi, United States
📍 Saint Louis, Missouri, United States
📍 Marlton, New Jersey, United States
📍 Staten Island, New York, United States
📍 Dayton, Ohio, United States
📍 North Canton, Ohio, United States
📍 Austin, Texas, United States
📍 DeSoto, Texas, United States
📍 Richardson, Texas, United States
More locations available...

📋 Eligibility Criteria

Description

    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 the screening 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, as confirmed by MINI interview with at least one well- defined prior mood episode (in addition to the current episode). The most recent prior manic episode must have occurred 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 psychotropic medications during the Screening Phase (e.g., antidepressant, antimanic, antipsychotic medications).

    Exclusion Criteria:

    • 1. Rapid cycling is excluded as defined herein by subjects who have experienced ≥ 6 distinct mood episodes in a year. Consecutive mood episodes must be demarcated either by a partial or full remission of at least 2 months' duration or by a switch to an episode of opposite polarity. Each manic or mixed episode must have lasted at least 1 week, and each hypomanic episode must have lasted at least 4 days.
    • 2. Participants with a confirmed lifetime history of schizophrenia, psychotic disorders, dementia, delirium, amnesia, neurodegenerative disease, traumatic brain injury with clinically significant sequalae, seizure disorder, or other neurocognitive disorder. Previous diagnosis of psychotic spectrum disorders are allowable if the Investigator deems the diagnosis to be describing symptoms related to bipolar disorder.
    • 3. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 May 2024
  • First Submitted that Met QC Criteria 14 May 2024
  • First Posted 17 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 July 2024
  • Last Update Posted 29 July 2024
  • Last Verified July 2024
I'm interested ...!!