Bipolar Disorder
Conditions
Keywords
bipolar, mania, manic episode, manic state, bipolar disorder type 1, manic depressive, manic bipolar, mixed features, mixed episode, mixed mania, bipolar episode
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.
Interventions
DRUGBHV-7000
BHV-7000 75 mg taken once daily for 21 days
DRUGPlacebo
Matching placebo taken once daily for 21 days
Sponsors
Biohaven Therapeutics Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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 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). Key
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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 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. |
| 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 | — |
| 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. |
Countries
United States
Outcome results
None listed