Schizophrenia AgitationPhase 4NCT06093451
Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
A Phase 4 study testing Dexmedetomidine and Lorazepam 2 MG/ML in people with Schizophrenia Agitation and Schizo Affective Disorder, run by Temple University at 1 site in United States.
Trial summary
An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder
- What is being tested?
- Dexmedetomidine and Lorazepam 2 MG/ML
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Jul 2024
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The participant is an adult between the ages of 18-55 at the time of study participation
- Hospitalized on an inpatient unit at Episcopal Hospital
- Meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, as determined by routine clinical assessment conducted upon admission.
- Are able to understand and read English
- Are able to provide informed consent
- Experiencing a moderate (PANSS-EC score ≥14 and <20) or severe (PANSS-EC score ≥20) episode of agitation
Who cannot join
- Women who are pregnant or breastfeeding
- Prisoners
- Participant has an allergy to dexmedetomidine or lorazepam
- Participant has mild, moderate or severe hepatic impairment
- Participant has active pulmonary disease and is receiving treatment (oxygen, inhalers)
- Individual is currently prescribed scheduled benzodiazepines or methadone
Show all 14Show fewer
- Participant history of QTc ≥ 500 msec or a history of arrythmia
- Participant recent (within the last 2 days) fall, syncope (passing out), feeling lightheaded, or pulse <50.
- Individual has a history of hypokalemia or hypomagnesemia within the past 2 years?
- Participant is receiving high-risk medications, including:
- Methadone
- Midazolam
- Opioids
- High risk medications associated with the QT interval prolongation (sertindole, chlorpromazine, ziprasidone), (amiodarone, iboga, quinine, arsenic, ibutilide, selpercatinib, ivosidenib, bedaquiline, lenvatinib, sotalol, levoketoconazole, cisapride, vendetanib, mobocertinib, disopyramide, papaverine)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Temple University Episcopal Hospital
Philadelphia, Pennsylvania, 19125
About this study
Official title: An Open-Label, Randomized, Active Controlled Inpatient Trial Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.
Read the detailed description
This is an open-label, randomized control trial where patients (N=32) with schizophrenia or bipolar disorder are randomized to receive either sublingual dexmedetomidine or oral lorazepam monotherapy for the treatment of episodic agitation. For moderate agitation (PANSS-EC score ≥14 and <20), patients will receive either sublingual dexmedetomidine 120mcg or oral lorazepam 2mg. For severe agitation (PANSS-EC ≥20), patients will receive either sublingual dexmedetomidine 180mcg or oral lorazepam 2mg. The PANSS-EC and ACES will be evaluated at baseline and after 15, 30, 60, and 120 minutes.
- Being tested
- Dexmedetomidine, Lorazepam 2 MG/ML
- Keywords
- Agitation, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder, Psychomotor Agitation, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Igalmi
Moderate agitation: 120 mcg Severe agitation: 180 mcg
Lorazepam 2 MG/MLDrug
Also called Ativan
2 mg
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Participants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed. Receives: Drug: Dexmedetomidine |
| Lorazapem | Active comparator | Participants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed. Receives: Drug: Lorazepam 2 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PANSS-EC score at 120 minutes after medication administration
Severity of agitation will be determined by administering the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC). Moderate to severe agitation will be defined as a PANSS-EC score >=14 and <20; and >= 20 is severe agitation.
Measured: Baseline and at 120 minutes
Secondary outcomes (5)
Change from baseline in ACES score at 15, 30, 60, 90, and 120 minutes, or prior to receipt of any rescue medication for agitation.
Severity of agitation will be measured using the standardized Agitation-Calmness Evaluation Scale. The 9-point scale indicated the degree of agitation as follows: 1=marked agitation, 4=normal behavior, 7 = marked calmness, 9=unarousable.
Measured: Baseline and 15, 30, 60, 90, and 120 minutes
Change in PANSS-EC score at 15, 30, 60, and 90 minutes, or prior to receipt of any rescue medication for agitation.
Severity of agitation will be determined by administering the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC). Moderate to severe agitation will be defined as a PANSS-EC score >=14 and <20; and >= 20 is severe agitation.
Measured: Baseline and 15, 30, 60, and 90 minutes
Patient tolerability assessed by adverse events of dexmedetomidine
Tolerability and safety of sublingual dexmedetomidine was assessed by evaluating spontaneously-reported adverse events. Treatment tolerability as assessed by adverse events will be tabulated by toxicity grade and organ systems as well as overall.
Measured: Baseline through 120 minutes after medication administration
Patient satisfaction based on Medication Satisfaction Questionnaire (MSQ)
Medication Satisfaction Questionnaire (MSQ) will be given to the subject to assess their satisfaction of their agitation medication two hours after initial medication administration. The Medication Satisfaction Questionnaire is a 7-point scale, with 1 being "Extremely Dissatisfied", 4 being "Neither Satisfied or Dissatisfied", and 7 being "Extremely Satisfied"
Measured: Administered 120 minutes after medication administration
Assess the need for rescue medication for agitation within two hours of medication administration
Need for rescue medication of sublingual dexmedetomidine will be assessed by reviewing the Medication Administration Reconciliation (MAR) available on the electronic medical record system for the two hour period of time following medication administration.
Measured: Baseline and 2 hours after medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia AgitationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- BioXcel Therapeutics Inc
- Responsible party
- Principal investigator, Justin Faden, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093451
- Sponsor's protocol ID
- 30561
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
San L, Marksteiner J, Zwanzger P, Figuero MA, Romero FT, Kyropoulos G, Peixoto AB, Chirita R, Boldeanu A. State of Acute Agitation at Psychiatric Emergencies in Europe: The STAGE Study. Clin Pract Epidemiol Ment Health. 2016 Oct 27;12:75-86. doi: 10.2174/1745017901612010075. eCollection 2016.
PubMed 27857778Cots F, Chiarello P, Perez V, Gracia A, Becerra V. Hospital Costs Associated With Agitation in the Acute Care Setting. Psychiatr Serv. 2016 Jan;67(1):124-7. doi: 10.1176/appi.ps.201400508. Epub 2015 Aug 3.
PubMed 26234333Rubio-Valera M, Luciano JV, Ortiz JM, Salvador-Carulla L, Gracia A, Serrano-Blanco A. Health service use and costs associated with aggressiveness or agitation and containment in adult psychiatric care: a systematic review of the evidence. BMC Psychiatry. 2015 Mar 4;15:35. doi: 10.1186/s12888-015-0417-x.
PubMed 25881240Richmond JS, Berlin JS, Fishkind AB, Holloman GH Jr, Zeller SL, Wilson MP, Rifai MA, Ng AT. Verbal De-escalation of the Agitated Patient: Consensus Statement of the American Association for Emergency Psychiatry Project BETA De-escalation Workgroup. West J Emerg Med. 2012 Feb;13(1):17-25. doi: 10.5811/westjem.2011.9.6864.
PubMed 22461917Wilson MP, Pepper D, Currier GW, Holloman GH Jr, Feifel D. The psychopharmacology of agitation: consensus statement of the american association for emergency psychiatry project Beta psychopharmacology workgroup. West J Emerg Med. 2012 Feb;13(1):26-34. doi: 10.5811/westjem.2011.9.6866.
PubMed 22461918Zeller SL, Citrome L. Managing Agitation Associated with Schizophrenia and Bipolar Disorder in the Emergency Setting. West J Emerg Med. 2016 Mar;17(2):165-72. doi: 10.5811/westjem.2015.12.28763. Epub 2016 Mar 2.
PubMed 26973742Preskorn SH, Zeller S, Citrome L, Finman J, Goldberg JF, Fava M, Kakar R, De Vivo M, Yocca FD, Risinger R. Effect of Sublingual Dexmedetomidine vs Placebo on Acute Agitation Associated With Bipolar Disorder: A Randomized Clinical Trial. JAMA. 2022 Feb 22;327(8):727-736. doi: 10.1001/jama.2022.0799.
PubMed 35191924Citrome L, Preskorn SH, Lauriello J, Krystal JH, Kakar R, Finman J, De Vivo M, Yocca FD, Risinger R, Rajachandran L. Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial. J Clin Psychiatry. 2022 Oct 3;83(6):22m14447. doi: 10.4088/JCP.22m14447.
PubMed 36198061Igalmi [package insert]. BioXcel Therapeutics, Inc; 2022.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Active Controlled Inpatient Trial Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06093451
- Acronym / sponsor ID
- 30561
- Keywords
- Agitation, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- BioXcel Therapeutics Inc
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 23 Oct 2023 (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.
An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.
Detailed description
This is an open-label, randomized control trial where patients (N=32) with schizophrenia or bipolar disorder are randomized to receive either sublingual dexmedetomidine or oral lorazepam monotherapy for the treatment of episodic agitation. For moderate agitation (PANSS-EC score ≥14 and <20), patients will receive either sublingual dexmedetomidine 120mcg or oral lorazepam 2mg. For severe agitation (PANSS-EC ≥20), patients will receive either sublingual dexmedetomidine 180mcg or oral lorazepam 2mg. The PANSS-EC and ACES will be evaluated at baseline and after 15, 30, 60, and 120 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineParticipants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed. |
| Lorazapem | Active comparator | Drug: Lorazepam 2 MG/MLParticipants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The participant is an adult between the ages of 18-55 at the time of study participation
- Hospitalized on an inpatient unit at Episcopal Hospital
- Meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, as determined by routine clinical assessment conducted upon admission.
- Are able to understand and read English
- Are able to provide informed consent
Key exclusion criteria (14 listed)
- Women who are pregnant or breastfeeding
- Prisoners
- Participant has an allergy to dexmedetomidine or lorazepam
- Participant has mild, moderate or severe hepatic impairment
- Participant has active pulmonary disease and is receiving treatment (oxygen, inhalers)
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 |
|---|---|---|
| DexmedetomidineAlso: IgalmiModerate agitation: 120 mcg Severe agitation: 180 mcg | Drug | Dexmedetomidine |
| Lorazepam 2 MG/MLAlso: Ativan2 mg | Drug | Lorazapem |
Primary outcome
Change in PANSS-EC score at 120 minutes after medication administration
Time frame: Baseline and at 120 minutes
Severity of agitation will be determined by administering the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC). Moderate to severe agitation will be defined as a PANSS-EC score >=14 and <20; and >= 20 is severe agitation.
5 secondary outcomes
Change from baseline in ACES score at 15, 30, 60, 90, and 120 minutes, or prior to receipt of any rescue medication for agitation.
Time frame: Baseline and 15, 30, 60, 90, and 120 minutes
Change in PANSS-EC score at 15, 30, 60, and 90 minutes, or prior to receipt of any rescue medication for agitation.
Time frame: Baseline and 15, 30, 60, and 90 minutes
Patient tolerability assessed by adverse events of dexmedetomidine
Time frame: Baseline through 120 minutes after medication administration
Patient satisfaction based on Medication Satisfaction Questionnaire (MSQ)
Time frame: Administered 120 minutes after medication administration
Assess the need for rescue medication for agitation within two hours of medication administration
Time frame: Baseline and 2 hours after medication administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 27857778San L, Marksteiner J, Zwanzger P, Figuero MA, Romero FT, Kyropoulos G, Peixoto AB, Chirita R, Boldeanu A. State of Acute Agitation at Psychiatric Emergencies in Europe: The STAGE Study. Clin Pract Epidemiol Ment Health. 2016 Oct 27;12:75-86. doi: 10.2174/1745017901612010075. eCollection 2016.
- Background: PubMed 26234333Cots F, Chiarello P, Perez V, Gracia A, Becerra V. Hospital Costs Associated With Agitation in the Acute Care Setting. Psychiatr Serv. 2016 Jan;67(1):124-7. doi: 10.1176/appi.ps.201400508. Epub 2015 Aug 3.
- Background: PubMed 25881240Rubio-Valera M, Luciano JV, Ortiz JM, Salvador-Carulla L, Gracia A, Serrano-Blanco A. Health service use and costs associated with aggressiveness or agitation and containment in adult psychiatric care: a systematic review of the evidence. BMC Psychiatry. 2015 Mar 4;15:35. doi: 10.1186/s12888-015-0417-x.
- Background: PubMed 22461917Richmond JS, Berlin JS, Fishkind AB, Holloman GH Jr, Zeller SL, Wilson MP, Rifai MA, Ng AT. Verbal De-escalation of the Agitated Patient: Consensus Statement of the American Association for Emergency Psychiatry Project BETA De-escalation Workgroup. West J Emerg Med. 2012 Feb;13(1):17-25. doi: 10.5811/westjem.2011.9.6864.
- Background: PubMed 22461918Wilson MP, Pepper D, Currier GW, Holloman GH Jr, Feifel D. The psychopharmacology of agitation: consensus statement of the american association for emergency psychiatry project Beta psychopharmacology workgroup. West J Emerg Med. 2012 Feb;13(1):26-34. doi: 10.5811/westjem.2011.9.6866.
- Background: PubMed 26973742Zeller SL, Citrome L. Managing Agitation Associated with Schizophrenia and Bipolar Disorder in the Emergency Setting. West J Emerg Med. 2016 Mar;17(2):165-72. doi: 10.5811/westjem.2015.12.28763. Epub 2016 Mar 2.
- Background: PubMed 35191924Preskorn SH, Zeller S, Citrome L, Finman J, Goldberg JF, Fava M, Kakar R, De Vivo M, Yocca FD, Risinger R. Effect of Sublingual Dexmedetomidine vs Placebo on Acute Agitation Associated With Bipolar Disorder: A Randomized Clinical Trial. JAMA. 2022 Feb 22;327(8):727-736. doi: 10.1001/jama.2022.0799.
- Background: PubMed 36198061Citrome L, Preskorn SH, Lauriello J, Krystal JH, Kakar R, Finman J, De Vivo M, Yocca FD, Risinger R, Rajachandran L. Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial. J Clin Psychiatry. 2022 Oct 3;83(6):22m14447. doi: 10.4088/JCP.22m14447.
- BackgroundIgalmi [package insert]. BioXcel Therapeutics, Inc; 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Lorazepam 2 MG/ML in people with Schizophrenia Agitation and Schizo Affective Disorder, run by Temple 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Faden, DO (2157070401, Justin.Faden@tuhs.temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PANSS-EC score at 120 minutes after medication administration (time frame: Baseline and at 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06093451, which also lists 9 linked publications.
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 Oct 2023.