Major Depressive DisorderPhase 2NCT06419608
Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression
A Phase 2 study testing BHV-7000 in people with Major Depressive Disorder, run by Biohaven Therapeutics Ltd. at 62 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- BHV-7000
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 62 sitesUnited States
- Study dates
- 28 May 2024to 7 Nov 2025
- Phase
- Phase 2
- 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
- Subjects experiencing a moderate to severe episode of depression.
- Subjects experiencing a current episode of depression for at least 2 months.
- Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study.
- Male and Female participants 18 to 75 years of age at the time of consent.
- Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.
Who cannot join
- Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.
- Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study.
- Subjects with a history of medical conditions that may interfere with the conduct of the study.
- Females who are pregnant, breastfeeding or planning to become pregnant.
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
Advanced Research Center, Inc.
Anaheim, California, 92805
Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners
Austin, Texas, 78737
Headlands Pharmasite
Baltimore, Maryland, 21208
Northwest Clinical Research Center
Bellevue, Washington, 98007
CIT LA
Bellflower, California, 90706
Copley Clinical
Boston, Massachusetts, 02116
Boston Clinical Trials
Boston, Massachusetts, 02131
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235
Neurobehavioral Research, Inc
Cedarhurst, New York, 11516
Uptown Research Institute
Chicago, Illinois, 60640
IPMG
Chino, California, 91710
Alpine Reseach Organization
Clinton, Utah, 84015
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910
FutureSearch Trials of Dallas
Dallas, Texas, 75234
Relaro Medical Trials, LLC
Dallas, Texas, 75243
CenExel iResearch, LLC
Decatur, Georgia, 30030
InSite Clinical Research, LLC
DeSoto, Texas, 75115
Revive Research Institute, Inc.
Elgin, Illinois, 60123
WR-PRI Encino
Encino, California, 91316
UConn Health
Farmington, Connecticut, 06030
Precise Clinical Research
Flowood, Mississippi, 39232
CBH Health
Gaithersburg, Maryland, 20877
Collaborative Neuroscience Research, LLC (CenExel - CNS)
Garden Grove, California, 92845
Red Oak Psychiatry Associates, PA
Houston, Texas, 77373
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
IMA Clinical Research
Las Vegas, Nevada, 89102
Pillar Clinical Research, LLC
Little Rock, Arkansas, 72204
WIRG
Little Rock, Arkansas, 72211
CalNeuro Research Group
Los Angeles, California, 90025
Suburban Research Associates
Media, Pennsylvania, 19063
Floridian Neuroscience Institute
Miami Lakes, Florida, 33016
Scranton Medical Institute
Moosic, Pennsylvania, 18509
Bioscience Research LLC
Mount Kisco, New York, 10549
Delricht Research
New Orleans, Louisiana, 70115
Berman Clinical
New York, New York, 10029
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
The Medical Research Network, LLC
New York, New York, 10128
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Optum Behavioral Care of Connecticut, PC dba Comprehensive Psychiatric Care of Connecticut
Norwich, Connecticut, 06360
Excell Research, Inc.
Oceanside, California, 92056
NRC Research Institute
Orange, California, 92868
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Collective Medical Research
Overland Park, Kansas, 66210
IMA Clinical Research
Phoenix, Arizona, 85012
Aim Trials
Plano, Texas, 75093
Anderson Clinical Research
Redlands, California, 92374
CIT IE
Riverside, California, 92506
WRN
Rogers, Arkansas, 72758
Lumos Clinical Research Center
San Jose, California, 95124
CenExel iResearch, LLC
Savannah, Georgia, 31405
Arch Clinical Trials
St Louis, Missouri, 63141
Stanford
Stanford, California, 94305
RBA
Staten Island, New York, 10329
K2 Medical Research
Tampa, Florida, 33607
Bio Behavioral Health
Toms River, New Jersey, 08755
Cenexel CNS
Torrance, California, 90504
Pacific Clinical Research Management Group
Upland, California, 91786
Sunwise Clinical Research
Walnut Creek, California, 94596
Adams Clinical
Watertown, Massachusetts, 02472
Neuroscience Research Institute
West Palm Beach, Florida, 33407
Grayline Research Center
Wichita Falls, Texas, 76309
About this study
Official title: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder
The purpose of this study is to determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Being tested
- BHV-7000, Placebo
- Keywords
- depression, depressed, depressive disorder, major depression, major depressive episode, antidepressant
- Medical subject headings
- Depressive Disorder, Major, Depression, Consciousness Disorders, Depressive Disorder
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 6 weeks
PlaceboDrug
Matching placebo taken once daily for 6 weeks
| 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 Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6
The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60).
Measured: Baseline to Week 6
Secondary outcomes (9)
Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score
The CGI-S is a clinician-rated scale to assess disease severity. The scale is scored on 8-point scale (0 [not assessed] to 7 [severe]). A higher score represents a higher severity illness.
Measured: Baseline to Week 6
Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6
The SHAPS is a subject self- administered scale to measure hedonic capacity which consists of 14 items (total scores range from 0 to 14). Each item has a set of 4 possible responses (Strongly or Definitely Agree, Agree, Disagree and Strongly Disagree). A total score is derived by summing the responses to each item. A higher score represents a higher level of anhedonia.
Measured: Baseline to Week 6
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1
The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60).
Measured: Baseline to Week 1
Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1
The SHAPS is a subject self- administered scale to measure hedonic capacity which consists of 14 items (total scores range from 0 to 14). Each item has a set of 4 possible responses (Strongly or Definitely Agree, Agree, Disagree and Strongly Disagree). A total score is derived by summing the responses to each item. A higher score represents a higher level of anhedonia.
Measured: Baseline to Week 1
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score
The Q-LES-Q-SF is a participant self-administered scale to assess the degree of enjoyment and satisfaction experienced in various areas of daily functioning. The form consists of 16 items. Each item is scored on 5-point scale. A higher score represents a higher level of satisfaction and enjoyment (total scores range from 14 to 70).
Measured: Baseline to Week 6
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication
Safety and tolerability of BHV-7000 as assessed by frequency of unique subjects with SAEs; AEs leading to discontinuation; AEs judged to be related to study medication
Measured: Screening through Week 8
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: Screening through Week 8
Number of Participants With Vital Sign Abnormalities
Measured: Screening through Week 8
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
Measured: Screening through Week 8
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 completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 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
- NCT06419608
- Sponsor's protocol ID
- BHV7000-305
- Status last verified
- Oct 2026
- First submitted
- 14 May 2024
- Last updated
- 14 Oct 2026
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06419608
- Acronym / sponsor ID
- BHV7000-305
- Conditions
- Major Depressive Disorder
- Keywords
- depression, depressed, depressive disorder, major depression, major depressive episode, antidepressant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 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 the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD)
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 (5 listed)
- Subjects experiencing a moderate to severe episode of depression.
- Subjects experiencing a current episode of depression for at least 2 months.
- Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study.
- Male and Female participants 18 to 75 years of age at the time of consent.
- Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.
Key exclusion criteria (4 listed)
- Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit.
- Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study.
- Subjects with a history of medical conditions that may interfere with the conduct of the study.
- Females who are pregnant, breastfeeding or planning to become pregnant.
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 6 weeks | Drug | BHV-7000 |
| PlaceboMatching placebo taken once daily for 6 weeks | Drug | Placebo |
Primary outcome
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6
Time frame: Baseline to Week 6
The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60).
9 secondary outcomes
Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score
Time frame: Baseline to Week 6
Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6
Time frame: Baseline to Week 6
Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1
Time frame: Baseline to Week 1
Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1
Time frame: Baseline to Week 1
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score
Time frame: Baseline to Week 6
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication
Time frame: Screening through Week 8
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Screening through Week 8
Number of Participants With Vital Sign Abnormalities
Time frame: Screening through Week 8
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
Time frame: Screening through Week 8
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 14 Oct 2026.
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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.
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BHV-7000 in people with Major Depressive Disorder, run by Biohaven Therapeutics Ltd. at 62 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 5 inclusion and 4 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 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 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.
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 Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6 (time frame: Baseline to Week 6). 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 14 Oct 2026.