Bipolar DisorderPhase 2/3NCT06419582
BHV-7000 Acute Treatment of Bipolar Mania
A Phase 2/3 study testing BHV-7000 in people with Bipolar Disorder, run by Biohaven Therapeutics Ltd. at 32 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- BHV-7000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 32 sitesUnited States
- Study dates
- 28 May 2024to 30 Jan 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Advanced Research Center, Inc.
Anaheim, California, 92805
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Community Clinical Research, Inc.
Austin, Texas, 78754
CIT LA
Bellflower, California, 90706
Pillar Clinical Research, LLC
Bentonville, Arkansas, 72712
Uptown Research Institute
Chicago, Illinois, 60640
Pillar Clinical Research
Chicago, Illinois, 60641
ProScience Research Group
Culver City, California, 90230
Midwest Clinical Research Center
Dayton, Ohio, 45417
CenExel iResearch, LLC
Decatur, Georgia, 30030
InSite Clinical Research, LLC
DeSoto, Texas, 75115
Precise Clinical Research
Flowood, Mississippi, 39232
CBH Health
Gaithersburg, Maryland, 20877
Cenexel CNS
Garden Grove, California, 92845
Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site
Hollywood, Florida, 33021
Cenexel - RCA
Hollywood, Florida, 33024
Synergy San Diego
Lemon Grove, California, 91945
WIRG
Little Rock, Arkansas, 72211
Hassman Research Institute
Marlton, New Jersey, 08053
LCC Medical Research Inst
Miami, Florida, 33126
Floridian Neuroscience Institute
Miami Lakes, Florida, 33016
Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site
Miami Lakes, Florida, 33016
NBCR
North Canton, Ohio, 44720
NRC Research Institute
Orange, California, 92868
Pillar Clinical Research, LLC
Richardson, Texas, 75080
CIT IE
Riverside, California, 92506
WRN
Rogers, Arkansas, 72758
CenExel iResearch, LLC
Savannah, Georgia, 31405
Arch Clinical Trials
St Louis, Missouri, 63141
RBA
Staten Island, New York, 10329
Cenexel CNS
Torrance, California, 90504
Neuroscience Research Institute
West Palm Beach, Florida, 33407
About this study
Official title: A Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
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
- Being tested
- BHV-7000, Placebo
- Keywords
- bipolar, mania, manic episode, manic state, bipolar disorder type 1, manic depressive, manic bipolar, mixed features, mixed episode, mixed mania, bipolar episode
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-7000Drug
BHV-7000 75 mg taken once daily for 21 days
PlaceboDrug
Matching placebo taken once daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| BHV-7000 | Experimental | Not described Receives: Drug: BHV-7000 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (day 1) to day 21
Secondary outcomes (10)
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.
Measured: Baseline (day 1) to day 21
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline (day 1) to day 21
Number of Participants With Vital Sign Abnormalities
Measured: Baseline (day 1) to day 21
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
Measured: Baseline (day 1) to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start28 May 2024
- Primary completion15 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Biohaven Therapeutics Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419582
- Sponsor's protocol ID
- BHV7000-204
- Status last verified
- Dec 2025
- First submitted
- 14 May 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT06419582
- Acronym / sponsor ID
- BHV7000-204
- Conditions
- Bipolar Disorder
- Keywords
- bipolar, mania, manic episode, manic state, bipolar disorder type 1, manic depressive, manic bipolar, mixed features
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHV-7000 | Experimental | Drug: BHV-7000 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHV-7000BHV-7000 75 mg taken once daily for 21 days | Drug | BHV-7000 |
| PlaceboMatching placebo taken once daily for 21 days | Drug | Placebo |
Primary outcome
Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21
Time frame: 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.
10 secondary outcomes
Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score
Time frame: Baseline (day 1) to day 21
Percentage of participants showing treatment response
Time frame: Baseline (day 1) to day 21
Percentage of participants showing treatment remission
Time frame: Baseline (day 1) to day 21
Change in Young Mania Rating Scale (YMRS) total score from baseline to day 7
Time frame: Baseline (day 1) to day 7
Change in Young Mania Rating Scale (YMRS) total score from baseline to day 4
Time frame: Baseline (day 1) to day 4
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 21
Time frame: 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
Time frame: Baseline (day 1) to day 21
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Baseline (day 1) to day 21
Number of Participants With Vital Sign Abnormalities
Time frame: Baseline (day 1) to day 21
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
Time frame: Baseline (day 1) to day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BHV-7000 in people with Bipolar Disorder, run by Biohaven Therapeutics Ltd. at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21 (time frame: Baseline (day 1) to day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.