BHV-7000 Acute Treatment of Bipolar Mania
- Registration Number
- NCT06419582
- Lead Sponsor
- Biohaven Therapeutics Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
- Participant must be voluntarily hospitalized for a current manic episode.
- Male and female participants 18 years to 75 years of age at the time of the screening visit.
- Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.
- 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.
- Episode of mania must not exceed 12 weeks in duration.
- Participants must be able and willing to discontinue all other psychotropic medications during the Screening Phase (e.g., antidepressant, antimanic, antipsychotic medications).
Key
- 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.
- 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.
- Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BHV-7000 BHV-7000 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21 Baseline (day 1) to day 21 The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.
- Secondary Outcome Measures
Name Time Method Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score Baseline (day 1) to day 21 This objective will be measured by the change in Clinical Global Impression of Severity (CGI-S) score from baseline (day 1) to day 21). The CGI-S is a global index of patient disease severity as rated by the clinician on a scale from 1 to 7, where 7 represents most severe patients.
Percentage of participants showing treatment response Baseline (day 1) to day 21 Treatment response is defined as greater than or equal to 50% reduction from baseline to day 21 on the YMRS total score.
The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.Percentage of participants showing treatment remission Baseline (day 1) to day 21 Treatment remission is defined as score of less than or equal to 12 on the YMRS total score from baseline to day 21.
The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.Change in Young Mania Rating Scale (YMRS) total score from baseline to day 7 Baseline (day 1) to day 7 This objective will be measured by the change in YMRS total score from baseline (day 1) to day 7. The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60).
The higher the YMRS score, the more severe the subject's symptoms of mania.Number of Participants With Clinically Significant Laboratory Abnormalities Baseline (day 1) to day 21 To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
Change in Young Mania Rating Scale (YMRS) total score from baseline to day 4 Baseline (day 1) to day 4 This objective will be measured by the change in YMRS total score from baseline (day 1) to day 4. The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60).
The higher the YMRS score, the more severe the subject's symptoms of mania.Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 21 Baseline (day 1) to day 21 This objective will be measured by the change in MADRS total score from baseline (day 1) to day 21. The MADRS, Montgomery-Asberg Rating Scale, measures depression on a 10 item scale. The overall score ranges from 0 to 60. The higher the MADRS score indicates more severe depression.
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication Baseline (day 1) to day 21 To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation, AEs judged to be related to study medication that are observed during the Double-blind Treatment Phase (21 days).
Number of Participants With Vital Sign Abnormalities Baseline (day 1) to day 21 Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation Baseline (day 1) to day 21
Trial Locations
- Locations (29)
Pillar Clinical Research, LLC
🇺🇸Richardson, Texas, United States
WIRG
🇺🇸Little Rock, Arkansas, United States
WRN
🇺🇸Rogers, Arkansas, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
CIT LA
🇺🇸Bellflower, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Cenexel CNS
🇺🇸Torrance, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
CIT IE
🇺🇸Riverside, California, United States
Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site
🇺🇸Hollywood, Florida, United States
Cenexel - RCA
🇺🇸Hollywood, Florida, United States
Floridian Neuroscience Institute
🇺🇸Miami Lakes, Florida, United States
Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site
🇺🇸Miami Lakes, Florida, United States
LCC Medical Research Inst
🇺🇸Miami, Florida, United States
Neuroscience Research Institute
🇺🇸West Palm Beach, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
CenExel iResearch, LLC
🇺🇸Savannah, Georgia, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
Pillar Clinical Research
🇺🇸Chicago, Illinois, United States
CBH Health
🇺🇸Gaithersburg, Maryland, United States
Precise Clinical Research
🇺🇸Flowood, Mississippi, United States
Arch Clinical Trials
🇺🇸Saint Louis, Missouri, United States
Hassman Research Institute
🇺🇸Marlton, New Jersey, United States
RBA
🇺🇸Staten Island, New York, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
NBCR
🇺🇸North Canton, Ohio, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
InSite Clinical Research, LLC
🇺🇸DeSoto, Texas, United States