SchizophreniaPhase 1DEXNCT03708315
BXCL501 for Agitation in Schizophrenia
A Phase 1 study testing Dexmedetomidine Hydrochloride in people with Schizophrenia and Schizoaffective Disorder, run by Yale University at 1 site in United States.
Trial summary
Agitation is characterized by excessive motor or verbal activity, irritability, uncooperativeness, threatening gestures, and, in some cases, aggressive or violent behavior. While agitation may have various underlying causes, patients with schizophrenia are especially vulnerable to acute episodes of agitation… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Dexmedetomidine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 26 May 2023
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give informed consent.
- Male or female between 18 and 65 years of age, inclusive
- According to DSM-V meet criteria for Schizophrenia or Schizoaffective disorder.
Who cannot join
- Current significant medical condition or other comorbidities
- Current substance dependence
- Women who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
Official title: Safety and Efficacy of BXCL501, a Sublingual Film Delivery of Dexmedetomidine for the Treatment of Acute Agitation in Schizophrenia
Agitation is characterized by excessive motor or verbal activity, irritability, uncooperativeness, threatening gestures, and, in some cases, aggressive or violent behavior. While agitation may have various underlying causes, patients with schizophrenia are especially vulnerable to acute episodes of agitation, especially during exacerbation of disease, and clinicians do not always diagnose these episodes early enough. Agitation associated with psychosis is a frequent reason for emergency department visits, and unless it is recognized early and managed effectively, it can rapidly escalate to potentially dangerous behaviors, including physical violence. Educating psychiatric professionals about the timely and accurate diagnosis of agitation among patients with schizophrenia or bipolar disorder and developing a well-tolerated easily administered medication will contribute to the prompt and effective management of this condition and could help reduce the risk of violent behavior and other undesirable outcomes. This study is designed to identify the ideal dose range and tolerability of sublingual Dexmedetomidine in patients with schizophrenia.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Dexmedetomidine Hydrochloride, Placebos
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
Also called Precedex
Dexmedetomidine Hydrochloride
PlacebosDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Order 1 | Active comparator | Subjects will be given a sublingual formulation of BXCL501 (dexmedetomidine) Receives: Drug: Dexmedetomidine Hydrochloride |
| Order 2 | Placebo comparator | Subjects will be given a sublingual film of placebo. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale Excited Component (PANSS-EC)
PANSS-EC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored from 1 (minimum) to 7 (maximum). The PANSS-EC is the sum of these 5 subscales and ranges from 5 to 35.
Measured: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
Skin conductance response (SCR)
SCR is one of the fastest-responding measures of stress response and arousal. Along with changes in heart rate, it has been found to be one of the most robust and non-invasive physiological measures of autonomic nervous system activity.
Measured: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
Heart rate variability
Heart rate variability (HRV) is a measure of the variability in time intervals between heart beats and is sensitive to sympathetic activity as well as worsening of psychosis/agitation.
Measured: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
Blood pressure
Systolic and diastolic blood pressure
Measured: Measured at screening, prior to administartion, approximately every 15 minutes post drug administration, and one day after drug administration
Agitation-Calmness Scale (ACES)
Designed to assess the clinical levels of calmness and sedation. This is a 9-point scale that differentiates between agitation, calmness, and sleep states Scores range from 1 (marked agitation)-9 (unarousable).
Measured: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Richmond Agitation Sedation Scale (RASS)
The RASS is a 10-level rating scale ranging from "Combative" (+4) to "unarousable" (-5).
Measured: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Secondary outcomes (3)
Behavioral Activity Rating Scale (BARS)
Ranging from 1 to 7 where: 1 = difficult or unable to rouse, 2 = asleep but responds normally to verbal or physical contact, 3 = drowsy, appears sedated, 4 = quiet, and awake (normal level of activity), 5 = signs of overt (physical or verbal) activity, calms down with instructions, 6 = extremely or continuously active, not requiring restraint, 7 = violent, requires restraint.
Measured: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Clinical Global Impressions-Improvement Scale (CGI-I)
Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.
Measured: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
Adverse Effects
To determine any adverse effects on blood pressure, heart rate, or respiratory drive occurs before or coincident with the achievement of the aforementioned level of sedation.
Measured: Assessed prior to dosing, throughout study drug administration, and up to one week after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start9 Mar 2020
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The subjects will be randomized and will get either a sublingual formulation of dexmedetomidine or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohini Ranganathan, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708315
- Sponsor's protocol ID
- 2000023998
- Acronym
- DEX
- Status last verified
- Jul 2025
- First submitted
- 12 Oct 2018
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of BXCL501, a Sublingual Film Delivery of Dexmedetomidine for the Treatment of Acute Agitation in Schizophrenia
- ClinicalTrials.gov ID
- NCT03708315
- Acronym / sponsor ID
- DEX / 2000023998
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 17 Oct 2018 (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.
Agitation is characterized by excessive motor or verbal activity, irritability, uncooperativeness, threatening gestures, and, in some cases, aggressive or violent behavior. While agitation may have various underlying causes, patients with schizophrenia are especially vulnerable to acute episodes of agitation, especially during exacerbation of disease, and clinicians do not always diagnose these episodes early enough. Agitation associated with psychosis is a frequent reason for emergency department visits, and unless it is recognized early and managed effectively, it can rapidly escalate to potentially dangerous behaviors, including physical violence. Educating psychiatric professionals about the timely and accurate diagnosis of agitation among patients with schizophrenia or bipolar disorder and developing a well-tolerated easily administered medication will contribute to the prompt and effective management of this condition and could help reduce the risk of violent behavior and other undesirable outcomes. This study is designed to identify the ideal dose range and tolerability of sublingual Dexmedetomidine in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The subjects will be randomized and will get either a sublingual formulation of dexmedetomidine or placebo.
| Arm | Type | Receives |
|---|---|---|
| Order 1 | Active comparator | Drug: Dexmedetomidine HydrochlorideSubjects will be given a sublingual formulation of BXCL501 (dexmedetomidine) |
| Order 2 | Placebo comparator | Drug: PlacebosSubjects will be given a sublingual film of placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to give informed consent.
- Male or female between 18 and 65 years of age, inclusive
- According to DSM-V meet criteria for Schizophrenia or Schizoaffective disorder.
Key exclusion criteria (3 listed)
- Current significant medical condition or other comorbidities
- Current substance dependence
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| Dexmedetomidine HydrochlorideAlso: PrecedexDexmedetomidine Hydrochloride | Drug | Order 1 |
| PlacebosPlacebo | Drug | Order 2 |
Primary outcome
Positive and Negative Symptom Scale Excited Component (PANSS-EC)
Time frame: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
PANSS-EC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored from 1 (minimum) to 7 (maximum). The PANSS-EC is the sum of these 5 subscales and ranges from 5 to 35.
Skin conductance response (SCR)
Time frame: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
SCR is one of the fastest-responding measures of stress response and arousal. Along with changes in heart rate, it has been found to be one of the most robust and non-invasive physiological measures of autonomic nervous system activity.
Heart rate variability
Time frame: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
Heart rate variability (HRV) is a measure of the variability in time intervals between heart beats and is sensitive to sympathetic activity as well as worsening of psychosis/agitation.
Blood pressure
Time frame: Measured at screening, prior to administartion, approximately every 15 minutes post drug administration, and one day after drug administration
Systolic and diastolic blood pressure
Agitation-Calmness Scale (ACES)
Time frame: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Designed to assess the clinical levels of calmness and sedation. This is a 9-point scale that differentiates between agitation, calmness, and sleep states Scores range from 1 (marked agitation)-9 (unarousable).
Richmond Agitation Sedation Scale (RASS)
Time frame: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
The RASS is a 10-level rating scale ranging from "Combative" (+4) to "unarousable" (-5).
3 secondary outcomes
Behavioral Activity Rating Scale (BARS)
Time frame: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Clinical Global Impressions-Improvement Scale (CGI-I)
Time frame: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
Adverse Effects
Time frame: Assessed prior to dosing, throughout study drug administration, and up to one week after drug administration
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 23 Jul 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.
Mohini Ranganathan, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine Hydrochloride in people with Schizophrenia and Schizoaffective Disorder, run by Yale University at 1 site 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 3 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Positive and Negative Symptom Scale Excited Component (PANSS-EC) (time frame: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.). The study lists 6 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 23 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.