- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05658510
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
December 7, 2023 updated by: BioXcel Therapeutics Inc
Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar Disorder
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder.
This study compares the study drug to a placebo.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, double-blind, placebo-controlled, 2-Part, Phase III study to assess the efficacy, safety, and tolerability of a 60 mcg dose of BXCL501 in adult (18-75 years old) males and females with agitation episodes associated with a primary diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder.
Part 1 of the study is a one-day, in-clinic treatment, and post-treatment observation period with patients experiencing an acute episode of agitation.
Part 2 of the study is a 12-week study to determine the safety of BXCL501 when used as needed for episodes of agitation at home.
Study Type
Interventional
Enrollment (Estimated)
450
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephen Gorny
- Phone Number: 475-228-2016
- Email: sgorny@bioxceltherapeutics.com
Study Contact Backup
- Name: Carl Gommoll, MS
- Phone Number: 475-355-5177
- Email: cgommoll@bioxceltherapeutics.com
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72211
- BioXcel Clinical Research Site 112
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Little Rock, Arkansas, United States, 72211
- BioXcel Clinical Research Site 119
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California
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Bellflower, California, United States, 90706
- BioXcel Clinical Research Site 113
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Cerritos, California, United States, 90703
- BioXcel Clinical Research Site 128
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Culver City, California, United States, 90230
- BioXcel Clinical Research Site 110
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Garden Grove, California, United States, 92845
- BioXcel Clinical Research Site 108
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Lemon Grove, California, United States, 91945
- BioXcel Clinical Research Site 117
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Los Angeles, California, United States, 90015
- BioXcel Clinical Research Site 121
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Oceanside, California, United States, 92056
- BioXcel Clinical Research Site 123
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Orange, California, United States, 92868
- BioXcel Clinical Research Site 104
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Rancho Cucamonga, California, United States, 91730
- BioXcel Clinical Research Site 133
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Riverside, California, United States, 92506
- BioXcel Clinical Research Site 114
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Colorado
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Denver, Colorado, United States, 80209
- BioXcel Clinical Research Site 129
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Florida
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Miami, Florida, United States, 33122
- BioXcel Clinical Research Site 131
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Miami, Florida, United States, 33186
- BioXcel Clinical Research Site 124
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Oakland Park, Florida, United States, 33334
- BioXcel Clinical Research Site 134
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Georgia
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Atlanta, Georgia, United States, 30331
- Bioxcel Clinical Research Site 106
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Decatur, Georgia, United States, 30030
- BioXcel Clinical Research Site 107
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Illinois
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Chicago, Illinois, United States, 60640
- BioXcel Clinical Research Site 109
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Elgin, Illinois, United States, 60123
- BioXcel Clinical Research Site 130
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Maryland
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Gaithersburg, Maryland, United States, 20877
- BioXcel Clinical Research Site 103
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Nevada
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Las Vegas, Nevada, United States, 89102
- BioXcel Clinical Research Site 118
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New Jersey
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Berlin, New Jersey, United States, 08009
- BioXcel Clinical Research Site 105
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Marlton, New Jersey, United States, 08053
- BioXcel Clinical Research Site 101
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Ohio
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Beachwood, Ohio, United States, 44122
- BioXcel Clinical Research Site 122
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Texas
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DeSoto, Texas, United States, 75115
- BioXcel Clinical Research Site 102
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Irving, Texas, United States, 75062
- BioXcel Clinical Research Site 125
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Plano, Texas, United States, 75093
- BioXcel Clinical Research Site 127
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Utah
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Murray, Utah, United States, 84107
- BioXcel Clinical Research Site 120
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Vermont
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Rutland, Vermont, United States, 05701
- BioXcel Clinical Research Site 132
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Washington
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Everett, Washington, United States, 98201
- BioXcel Clinical Research Site 126
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
A patient may enroll in only one part of the study; either Part 1 or Part 2.
Inclusion Criteria:
- Male and female patients between the ages of 18 to 75 years, inclusive
- Patients who can read, understand and provide written informed consent.
- Patients who have met Diagnostic and Statistical Manual5/5-Text Revision criteria for 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 before study participation based on a detailed medical history, a physical examination, a 12-lead ECG, a blood chemistry profile, hematology, and urinalysis.
- Participants who agree to use a medically acceptable and effective birth control method
Part 1 only
- Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PEC.
- Patients with a score of ≥4 on at least 1 of the 5 items on the PEC at Baseline.
Part 2 only
- Patients have had at least three clinical presentations of agitation requiring an intervention in the past three months prior to Screening
- Patients who are receiving stable treatment for the last 3 months prior to Screening for the underlying primary diagnosis and who are expected to remain on stable treatment for the duration of the study
- Patients who manage agitation episodes with as needed (PRN) medication
- The patient has an Informant who can read, understand, and provide written informed consent and understand and follow the study procedures
Exclusion Criteria:
- Patients with serious or unstable medical illnesses.
- 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
- Patients who are judged to be at significant risk of suicide
- Female patients who have a positive pregnancy test at Screening or Baseline, or are breastfeeding.
- Patients 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.
- History of syncope or other syncopal attacks, current evidence of hypovolemia, or orthostatic hypotension
- Patients with laboratory or ECG abnormalities considered clinically significant by the Investigator
- Patients who have received an investigational drug within 30 days before the study start
- Patients who have previously received BXCL501 via prescription (under the trade name IGALMI™) or received BXCL501 in an open-label clinical trial
- Patients considered by the Investigator to be unsuitable candidates for receiving dexmedetomidine or considered to be unsuitable for participating in the study for any reason.
Part 1 only
- Patients with agitation caused by acute intoxication, including identification of alcohol by breathalyzer or drugs of abuse (except for THC) during urine screening.
- Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 4 hours before study treatment.
- Patients who have previously received BXCL501 in a clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: 60 mcg of BXCL501
Sublingual film containing 60 Micrograms Dexmedetomidine
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Sublingual Film
Other Names:
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Placebo Comparator: Part 1: Matching Placebo
Sublingual Placebo film
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Sublingual Placebo Film
Other Names:
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Placebo Comparator: Part 2: Matching Placebo
Sublingual Placebo film
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Sublingual Placebo Film
Other Names:
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Experimental: Part 2: 80 mcg of BXCL501
Sublingual film containing 80 Micrograms Dexmedetomidine
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Sublingual Film
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total score
Time Frame: 2 hours
|
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum).
The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
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2 hours
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Part 2: Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Through study completion, an average of 12 weeks
|
To assess the safety of BXCL501 when used in an at-home environment based on treatment-emergent adverse events (TEAEs)
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Through study completion, an average of 12 weeks
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Part 2: Incidence of serious adverse events (SAEs)
Time Frame: Through study completion, an average of 12 weeks
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To assess the safety of BXCL501 when used in an at-home environment based on serious adverse events (SAEs)
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Through study completion, an average of 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: Clinical Global Impression - Improvement (CGI-I)
Time Frame: 2 hours
|
The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention.
The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse.
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2 hours
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Part 1: Change in Modified Clinical Global Impression - Severity (mCGI-S) scores from Baseline
Time Frame: 2 hours
|
The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation.
For this study, the mCGI-S is a 4-point scale where a score of 0 represents no agitation, and scores of 1-3 describe increasing severities of agitation (mild, moderate, severe).
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2 hours
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Part 1:The number of responders based on the Modified Clinical Global Impression - Severity (mCGI-S) score
Time Frame: 2 hours
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The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation.
A responder is characterized as a participant with a score of 0 (represents no agitation) or 1 (mild agitation)
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2 hours
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Part 1:Change from baseline in Agitation-Calmness Evaluation Scale (ACES)
Time Frame: 2 hours
|
The Agitation-Calmness Evaluation Scale (ACES) is a single item scale that measures overall agitation and sedation, where a score of 1 indicates marked agitation; 2 - moderate agitation; 3 - mild agitation; 4 - normal behavior; 5 - mild calmness; 6 - moderate calmness; 7 - marked calmness; 8 - deep sleep; and 9 - unarousable.
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2 hours
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Part 1: Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Through study completion, an average of 8 hours
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To assess the safety of BXCL501 based on treatment-emergent adverse events (TEAEs)
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Through study completion, an average of 8 hours
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Part 1: Change from baseline in heart rate (HR) at rest
Time Frame: Baseline, and 2, 4, 6, and 8 hours postdose
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The effect of BXCL501 on heart rate at rest
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Baseline, and 2, 4, 6, and 8 hours postdose
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Part 1: Change from baseline in heart rate (HR) under orthostatic stress
Time Frame: Baseline, and 2, 4, 6, and 8 hours postdose
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The effect of BXCL501 on heart rate under orthostatic stress
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Baseline, and 2, 4, 6, and 8 hours postdose
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Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at rest
Time Frame: Baseline, and 2, 4, 6, and 8 hours postdose
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The effect of BXCL501 on systolic and diastolic blood pressure at rest
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Baseline, and 2, 4, 6, and 8 hours postdose
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Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) under orthostatic stress
Time Frame: Baseline, and 2, 4, 6, and 8 hours postdose
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The effect of BXCL501 on systolic and diastolic blood pressure under orthostatic stress
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Baseline, and 2, 4, 6, and 8 hours postdose
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Part 1: Incidence of abnormal electrocardiograms (ECG) reported as an adverse event (AE)
Time Frame: Through study completion, an average of 8 hours
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Any abnormal ECG value that is reported as an adverse event (AE)
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Through study completion, an average of 8 hours
|
Part 1: Incidence of abnormal clinical laboratory values reported as an adverse event (AE)
Time Frame: Through study completion, an average of 8 hours
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Any abnormal clinical laboratory value that is reported as an adverse event (AE)
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Through study completion, an average of 8 hours
|
Part 2: Incidence of interactions with emergency services related to agitation
Time Frame: Through study completion, an average of 12 weeks
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Evaluate the impact of BXCL501 on the use of healthcare and emergency service resources because of agitation episodes
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Through study completion, an average of 12 weeks
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Part 2: Incidence of overall adverse events and AEs leading to discontinuation
Time Frame: Through study completion, an average of 12 weeks
|
To evaluate the safety and tolerability profile of BXCL501
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Through study completion, an average of 12 weeks
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Part 2: Proportion of patients who report somnolence (ACES score ≥8 reported by Informant) pre-dose to post-dose
Time Frame: 2 hours after each treatment for an episode of agitation
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To evaluate the safety and tolerability profile of BXCL501
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2 hours after each treatment for an episode of agitation
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Part 2: Proportion of patients who report somnolence (KSS score ≥8 reported by patient) pre-dose to post-dose
Time Frame: 2 hours after each treatment for an episode of agitation
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To evaluate the safety and tolerability profile of BXCL501
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2 hours after each treatment for an episode of agitation
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Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder
Time Frame: 2 hours after treatment for the first episode of agitation
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Proportion of patients with an improvement in agitation (Yes/No) post-dose for the first treated episode compared with placebo
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2 hours after treatment for the first episode of agitation
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Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder
Time Frame: 2 hours after treatment for the first episode of agitation
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Proportion of mCGI-S responders (patients who achieve a mCGI-S score of 0 or 1) following drug administration for the first treated episode
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2 hours after treatment for the first episode of agitation
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Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder
Time Frame: 2 hours after treatment for the first episode of agitation
|
Proportion of patients with a 1-point improvement in mCGI-S score following drug administration for the first treated episode
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2 hours after treatment for the first episode of agitation
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Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder
Time Frame: 2 hours after treatment for the first episode of agitation
|
Proportion of CGI-C responders (patients who achieve a CGI-C score of 1 or 2) following drug administration for the first treated episode
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2 hours after treatment for the first episode of agitation
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Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder
Time Frame: 2 hours after treatment for the first episode of agitation
|
Change in mCGI-S scores from pre-dose to post dose for the first treated episode
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2 hours after treatment for the first episode of agitation
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Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder
Time Frame: 2 hours after treatment for the first episode of agitation
|
CGI-C scores following drug administration for the first treated episode
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2 hours after treatment for the first episode of agitation
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Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder
Time Frame: Up to 24 hours after treatment for the first episode of agitation
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Time to end of an agitation episode from dosing for the first treated episode
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Up to 24 hours after treatment for the first episode of agitation
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Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation
Time Frame: 2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Proportion of patients with an improvement in agitation (Yes/No) post-dose for all treated episodes compared with placebo
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2 hours after treatment for all episodes of agitation, up to 12 weeks
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Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation
Time Frame: 2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Proportion of mCGI-S responders following drug administration for the last treated episode and all treated episodes
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2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation
Time Frame: 2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Proportion of patients with a 1-point improvement in mCGI-S score following drug administration for the last treated episode and all treated episodes
|
2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation
Time Frame: 2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Proportion of CGI-C responders following drug administration for the last treated episode and all treated episodes
|
2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation
Time Frame: 2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Change in mCGI-S scores from pre dose to post dose following drug administration for the last treated episode and all treated episodes
|
2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation
Time Frame: 2 hours after treatment for all episodes of agitation, up to 12 weeks
|
CGI-C scores following drug administration for the last treated episode and all treated episodes
|
2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation
Time Frame: Through study completion, an average of 12 weeks
|
The frequency of treated agitation episodes compared with placebo
|
Through study completion, an average of 12 weeks
|
Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation
Time Frame: Up to 24 hours after treatment for all episodes of agitation, up to 12 weeks
|
Time to end of an agitation episode from dosing for the last treated episode and across all treated episodes
|
Up to 24 hours after treatment for all episodes of agitation, up to 12 weeks
|
Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation
Time Frame: 2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Change in agitation behaviors scale following drug administration
|
2 hours after treatment for all episodes of agitation, up to 12 weeks
|
Part 2: Determine the overall clinical improvement after drug administration as measured by the use of rescue medications
Time Frame: Through study completion, an average of 12 weeks
|
Proportion of patients who receive rescue medication compared with placebo
|
Through study completion, an average of 12 weeks
|
Part 2: Determine the overall clinical improvement after drug administration as measured by the use of rescue medications
Time Frame: Through study completion, an average of 12 weeks
|
Time to use of rescue medication for patients receiving BXCL501 compared with placebo
|
Through study completion, an average of 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Robert Risinger, MD, BioXcel Therapeutics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2022
Primary Completion (Estimated)
March 30, 2025
Study Completion (Estimated)
March 30, 2025
Study Registration Dates
First Submitted
December 12, 2022
First Submitted That Met QC Criteria
December 12, 2022
First Posted (Actual)
December 20, 2022
Study Record Updates
Last Update Posted (Actual)
December 8, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Mood Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Schizophrenia Spectrum and Other Psychotic Disorders
- Dyskinesias
- Psychomotor Disorders
- Bipolar and Related Disorders
- Schizophrenia
- Psychotic Disorders
- Psychomotor Agitation
- Bipolar Disorder
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- BXCL501-401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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