Bipolar I DisorderPhase 2NCT07116694
Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
A Phase 2 study testing BXCL501 Sublingual Film in people with Bipolar I Disorder and Bipolar II Disorder, run by BioXcel Therapeutics Inc at 5 sites in United States.
Trial summary
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with Bipolar Disorders, Schizophrenia, Schizoaffective, and Schizophreniform disorders and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar I Disorder, Bipolar II Disorder, Schizophrenia
- What is being tested?
- BXCL501 Sublingual Film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Jun 2025to 7 Oct 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
- Male and female patients 18 to 75 years old, inclusive.
- Patients who can read, understand, and provide written informed consent.
- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, v5, Text Revision (DSM-5-TR) criteria for a primary diagnosis of bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder.
- Patients who, in the opinion of the principal investigator, are in good general health prior to study participation as determined by a detailed medical history, a physical examination, and a 12-lead electrocardiogram (ECG).
- Female participants, if of child-bearing potential and sexually active, and male participants, if sexually active with a partner of child-bearing potential, agree to use a medically acceptable and effective birth control method throughout the study and for one month following the end of the study.
- Based on history, in the past 30 days prior to Screening, patients must have had at least one clinical presentation of agitation requiring intervention.
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- Patients who are receiving stable psychotropic treatment for 30 days prior to Screening for the underlying primary diagnosis and who are expected to remain on stable treatment for the duration of the study.
- At least 18 years of age at the time of screening.
- Is a spouse, significant other, family member, friend, home health aide, or residence manager of an adult patient who:
- Has a clinical diagnosis of bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder.
- Is determined to be eligible for the study per the patient inclusion/exclusion criteria.
- Has known the patient for at least 12 months cumulatively.
- Currently living with or routinely contacting the patient at least five days a week.
- Does not plan to discontinue contact with the patient during the study period.
- Willing and able to provide written informed consent.
Who cannot join
- Patients with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, or hematologic disease.
- Psychiatric comorbidities are generally allowed; however, moderate or severe substance use disorders (SUD) (within the past 6 months) are exclusionary if the substance involved is other than nicotine or caffeine.
- The investigator believes the patient has a history of agitation episodes due to substance use.
- A diagnosis of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder that predated the diagnosis of schizophrenia or bipolar disorder, or in the opinion of the Investigator, is independent of the signs and symptoms of the schizophrenia or bipolar disorder.
- Suicidality as assessed with the Columbia Suicide Severity Rating Scale (C-SSRS). Clinically significant risk of suicide based on the Investigator's clinical opinion or a history of an actual suicide attempt in the last year are also exclusionary.
- Female patients who have a positive pregnancy test at screening/baseline or are breastfeeding.
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- Currently treated with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin), alpha-2 adrenergic agonists, or other prohibited medications.
- Patients with hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease, or focal neurological findings.
- Patients with ECG abnormalities considered clinically significant by the Investigator or qualified designee with clinical implications for the patient's participation in the study.
- Patients who have received an investigational drug within 30 days prior to Baseline.
- For any reason, patients considered by the Investigator, or designee, to be unsuitable candidates for receiving dexmedetomidine, e.g., patients with a history of allergic reactions to dexmedetomidine.
- Appears to have an impairment (e.g., cognitive, hearing, visual) or insufficient knowledge of the English language that could interfere with their ability to provide written consent, complete written assessments, or an interview (based on screener judgment).
- Unable to accompany the patient and remain present at the clinical site to complete ratings for the full two-hour data collection period while the patient experiences an acute agitation episode that needs to be treated.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
BioXcel Clinical Research Site 103
Chino, California, 91710
BioXcel Clinical Research Site 106
Las Vegas, Nevada, 89119
BioXcel Clinical Research Site 105
Oceanside, California, 92056
BioXcel Clinical Research Site 102
Orange, California, 92868
BioXcel Clinical Research Site 101
St Louis, Missouri, 63125
About this study
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with Bipolar Disorders, Schizophrenia, Schizoaffective, and Schizophreniform disorders and correlate them with clinician-assessed ratings.
Read the detailed description
This is an open-label study to assess acute psychomotor agitation measures in patient-informant dyads with adult (18-75 years old) males and females experiencing an agitation episode associated with bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder. This validation study will include collecting data from approximately 30 patient-informant dyads during and following an acute psychomotor agitation episode. Data will be collected during the episodes from the dyads and the clinical rater for up to two hours after baseline. The aim of the informant, patient, and investigator ratings will be to assess rater agreement between investigators and informants, as well as investigators and patients.
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Psychomotor Agitation
- Being tested
- BXCL501 Sublingual Film
- Medical subject headings
- Bipolar Disorder, Schizophrenia, Psychotic Disorders, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXCL501 Sublingual FilmDrug
Also called Dexmedetomidine
Single dose BXCL501 120 mcg
| Study group | Role | What they receive |
|---|---|---|
| BXCL501 Sublingual film | Experimental | Experimental: 120 mcg of BXCL501 Sublingual film containing 120 Micrograms Dexmedetomidine Receives: Drug: BXCL501 Sublingual Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Informant and Clinician ratings comparison
The aim of the study is to assess the agreement/correlations among different measures so the comment is correct that different units of measure are being assessed. The informant-completed questionnaire (modified clinical global impression of severity for informants (mCGI-S-INF) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-INF is a single item with a 0 to 3 point scale with higher values indicating more severe agitation. The PEC is a five item questionnaire with 7-point response options, overall scores range from 5 to 35 with higher scores indicating more severe agitation.
Measured: Before and 2 hours after the intervention
Informant training materials assessment
Assess content validity of the Modified Clinical Global Impression of Severity for Informants (mCGI-S-INF) and informant training materials. The scale being utilized is mCGI-S-INF. There is no score as it is a qualitative assessment and it is being validated to measure patient informant reported outcomes against patient reported outcomes (mCGI-S-PAT) and physician reported outcomes using the Positive and Negative Syndrome Scale - Excited Component (PEC) scale where the highest score indicates the maximum agitation that could be experienced.
Measured: Within 7 days of the intervention
Secondary outcomes (3)
Patient and Clinician ratings comparison
The aim of the study is to assess the agreement/correlations among different measures so the comment is correct that different units of measure are being assessed. The patient-completed questionnaire (modified clinical global impression of severity for patients (mCGI-S-P) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-P is a single item with a 0 to 3 point scale with higher values indicating more severe agitation. The PEC is a five item questionnaire with 7-point response options, overall scores range from 5 to 35 with higher scores indicating more severe agitation.
Measured: Before and 2 hours after the intervention
Patient training materials assessment
Assess content validity of the Modified Clinical Global Impression of Severity for Patients (mCGI-S-PAT) training materials. The scale being utilized is mCGI-S-PAT. There is no score as it is a qualitative assessment and is being validated to measure patient reported outcomes against physician reported outcomes using the Positive and Negative Syndrome Scale - Excited Component (PEC) scale where the highest score indicates the maximum agitation that could be experienced.
Measured: Within 7 days of the intervention
Patients completion of the Modified Clinical Global Impression of Severity for Patients (mCGI-S-PAT)
Evaluate whether patients with acute psychomotor agitation can complete the Modified Clinical Global Impression of Severity for Patients (mCGI-S-PAT) evaluation tool. The mCGI-S-PAT is already in the trial protocol and this protocol so it would be disruptive to rename the item at this point. The measure assesses severity of agitation 'right now' with response options of none, mild, moderate, and severe.
Measured: Before and 2 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start19 Jun 2025
- Primary completion7 Oct 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioXcel Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- BioXcel MM, Study chair, BioXcel Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116694
- Sponsor's protocol ID
- BXCL501-402
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar Disorder
- ClinicalTrials.gov ID
- NCT07116694
- Acronym / sponsor ID
- BXCL501-402
- Conditions
- Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Psychomotor Agitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BioXcel Therapeutics IncIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 11 Aug 2025 (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.
This open-label study will utilize treatment with BXCL501 in order to assess the suitability of patient-and lay informant-assessed outcome measures for evaluation of severity of psychomotor agitation episodes in patients with Bipolar Disorders, Schizophrenia, Schizoaffective, and Schizophreniform disorders and correlate them with clinician-assessed ratings.
Detailed description
This is an open-label study to assess acute psychomotor agitation measures in patient-informant dyads with adult (18-75 years old) males and females experiencing an agitation episode associated with bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder. This validation study will include collecting data from approximately 30 patient-informant dyads during and following an acute psychomotor agitation episode. Data will be collected during the episodes from the dyads and the clinical rater for up to two hours after baseline. The aim of the informant, patient, and investigator ratings will be to assess rater agreement between investigators and informants, as well as investigators and patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| BXCL501 Sublingual film | Experimental | Drug: BXCL501 Sublingual FilmExperimental: 120 mcg of BXCL501 Sublingual film containing 120 Micrograms Dexmedetomidine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male and female patients 18 to 75 years old, inclusive.
- Patients who can read, understand, and provide written informed consent.
- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, v5, Text Revision (DSM-5-TR) criteria for a primary diagnosis of bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder.
- Patients who, in the opinion of the principal investigator, are in good general health prior to study participation as determined by a detailed medical history, a physical examination, and a 12-lead electrocardiogram (ECG).
- Female participants, if of child-bearing potential and sexually active, and male participants, if sexually active with a partner of child-bearing potential, agree to use a medically acceptable and effective birth control method throughout the study and for one month following the end of the study.
Key exclusion criteria (13 listed)
- Patients with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, or hematologic disease.
- Psychiatric comorbidities are generally allowed; however, moderate or severe substance use disorders (SUD) (within the past 6 months) are exclusionary if the substance involved is other than nicotine or caffeine.
- The investigator believes the patient has a history of agitation episodes due to substance use.
- A diagnosis of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder that predated the diagnosis of schizophrenia or bipolar disorder, or in the opinion of the Investigator, is independent of the signs and symptoms of the schizophrenia or bipolar disorder.
- Suicidality as assessed with the Columbia Suicide Severity Rating Scale (C-SSRS). Clinically significant risk of suicide based on the Investigator's clinical opinion or a history of an actual suicide attempt in the last year are also exclusionary.
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 |
|---|---|---|
| BXCL501 Sublingual FilmAlso: DexmedetomidineSingle dose BXCL501 120 mcg | Drug | BXCL501 Sublingual film |
Primary outcome
Informant and Clinician ratings comparison
Time frame: Before and 2 hours after the intervention
The aim of the study is to assess the agreement/correlations among different measures so the comment is correct that different units of measure are being assessed. The informant-completed questionnaire (modified clinical global impression of severity for informants (mCGI-S-INF) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-INF is a single item with a 0 to 3 point scale with higher values indicating more severe agitation. The PEC is a five item questionnaire with 7-point response options, overall scores range from 5 to 35 with higher scores indicating more severe agitation.
Informant training materials assessment
Time frame: Within 7 days of the intervention
Assess content validity of the Modified Clinical Global Impression of Severity for Informants (mCGI-S-INF) and informant training materials. The scale being utilized is mCGI-S-INF. There is no score as it is a qualitative assessment and it is being validated to measure patient informant reported outcomes against patient reported outcomes (mCGI-S-PAT) and physician reported outcomes using the Positive and Negative Syndrome Scale - Excited Component (PEC) scale where the highest score indicates the maximum agitation that could be experienced.
3 secondary outcomes
Patient and Clinician ratings comparison
Time frame: Before and 2 hours after the intervention
Patient training materials assessment
Time frame: Within 7 days of the intervention
Patients completion of the Modified Clinical Global Impression of Severity for Patients (mCGI-S-PAT)
Time frame: Before and 2 hours after the intervention
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
BioXcel MM study chair
BioXcel Therapeutics
5 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 BXCL501 Sublingual Film in people with Bipolar I Disorder and Bipolar II Disorder, run by BioXcel Therapeutics Inc at 5 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 15 inclusion and 13 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 5 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 5 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. 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?
Informant and Clinician ratings comparison (time frame: Before and 2 hours after the intervention). The study lists 2 primary outcomes in all. 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 5 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.