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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-7000 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHV-7000 | Drug | BHV-7000 75 mg taken once daily for 21 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Young Mania Rating Scale (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. | Baseline (day 1) to day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score | 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. | Baseline (day 1) to day 21 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pillar Clinical Research, LLC | Bentonville | Arkansas | 72712 | United States | ||
| WIRG |
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| Placebo |
| Drug |
Matching placebo taken once daily for 21 days |
|
| Percentage of participants showing treatment response | 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. | Baseline (day 1) to day 21 |
| Percentage of participants showing treatment remission | 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. | Baseline (day 1) to day 21 |
| Change in Young Mania Rating Scale (YMRS) total score from baseline 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. | Baseline (day 1) to day 7 |
| Change in Young Mania Rating Scale (YMRS) total score from baseline 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. | Baseline (day 1) to day 4 |
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline 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. | Baseline (day 1) to day 21 |
| Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication | 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). | Baseline (day 1) to day 21 |
| Number of Participants With Clinically Significant Laboratory Abnormalities | 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. | Baseline (day 1) to day 21 |
| 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 |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| WRN | Rogers | Arkansas | 72758 | United States |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | United States |
| CIT LA | Bellflower | California | 90706 | United States |
| ProScience Research Group | Culver City | California | 90230 | United States |
| Cenexel CNS | Garden Grove | California | 92845 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| CIT IE | Riverside | California | 92506 | United States |
| Cenexel CNS | Torrance | California | 90504 | United States |
| Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site | Hollywood | Florida | 33021 | United States |
| Cenexel - RCA | Hollywood | Florida | 33024 | United States |
| LCC Medical Research Inst | Miami | Florida | 33126 | United States |
| Floridian Neuroscience Institute | Miami Lakes | Florida | 33016 | United States |
| Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site | Miami Lakes | Florida | 33016 | United States |
| Neuroscience Research Institute | West Palm Beach | Florida | 33407 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| CenExel iResearch, LLC | Decatur | Georgia | 30030 | United States |
| CenExel iResearch, LLC | Savannah | Georgia | 31405 | United States |
| Uptown Research Institute | Chicago | Illinois | 60640 | United States |
| Pillar Clinical Research | Chicago | Illinois | 60641 | United States |
| CBH Health | Gaithersburg | Maryland | 20877 | United States |
| Precise Clinical Research | Flowood | Mississippi | 39232 | United States |
| Arch Clinical Trials | St Louis | Missouri | 63141 | United States |
| Hassman Research Institute | Marlton | New Jersey | 08053 | United States |
| RBA | Staten Island | New York | 10329 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| NBCR | North Canton | Ohio | 44720 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| InSite Clinical Research, LLC | DeSoto | Texas | 75115 | United States |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | United States |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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