A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)
Primary Purpose
Schizophrenia, Schizophrenia; Psychosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Xanomeline and Trospium Chloride Capsules
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Subject is aged 18 to 65 years, inclusive, at screening.
Subject is capable of providing informed consent.
- A signed informed consent form must be provided before any study assessments are performed.
- Subject must be fluent (oral and written) in English or local language to consent
- Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2.
Subject is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening.
- The subject requires hospitalization for this acute exacerbation or relapse of psychotic symptoms.
- If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
Positive and Negative Syndrome Scale total score between 80 and 120, inclusive. Score of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items:
- Item 1 (P1; delusions)
- Item 2 (P2; conceptual disorganization)
- Item 3 (P3; hallucinatory behavior)
- Item 6 (P6; suspiciousness/persecution)
- Subjects with no change (improvement) in PANSS total score between screening and baseline (Day -1) of more than 20%.
- Subject has a CGI-S score of ≥4 at screening and baseline (Day -1) visits.
- Subject will have been off lithium therapy for at least 2 weeks before baseline and free of all oral antipsychotic medications for at least 5 half-lives or 1 week, whichever is longer, before baseline (Day -1).
- Subjects taking a long-acting injectable antipsychotic could not have received a dose of medication for at least 12 weeks (24 weeks for INVEGA TRINZA) before baseline visit (Day -1).
- Subject is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
- BMI must be ≥18 and ≤40 kg/m2.
- Subject resides in a stable living situation and is anticipated to return to that same stable living situation after discharge, in the opinion of the investigator.
- Subject has an identified reliable informant/caregiver.
- Women of childbearing potential, or men with sexual partners of childbearing potential, must be able and willing to use at least 1 highly effective method of contraception during the study and for 30 days after the last dose of study drug. Sperm donation is not allowed for 30 days after the final dose of study drug.
Exclusion Criteria:
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening). Symptoms of mild mood dysphoria or anxiety are allowed as long as these symptoms are not the primary focus of treatment. A screening subject with mild substance abuse disorder within the 12 months before screening must be discussed and agreed upon with the medical monitor before they can be allowed into the study.
- Subjects who are newly diagnosed or are experiencing their first treated episode of schizophrenia.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
- Subjects with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results.
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
- History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS).
- Clinically significant abnormal finding on the physical examination, medical history, ECG, or clinical laboratory results at screening.
- Subjects cannot currently (within 5 half-lives or 1 week, whichever is longer, before baseline [Day -1]) be receiving oral antipsychotic medications; monoamine oxidase inhibitors; anticonvulsants (eg, lamotrigine, Depakote); tricyclic antidepressants (eg, imipramine, desipramine); selective serotonin reuptake inhibitors; or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam, chloral hydrate).
- Pregnant, lactating, or less than 3 months postpartum.
- If, in the opinion of the investigator (and/or Sponsor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator (and/or Sponsor), may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements.
- Positive test for coronavirus (COVID-19) within 2 weeks before screening and at screening.
- Subjects with extreme concerns relating to global pandemics, such as COVID-19, that preclude study participation.
- Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening.
- Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) or required clozapine within the last 12 months.
- Subjects with prior exposure to KarXT.
- Subjects who experienced any adverse effects due to xanomeline or trospium.
- Participation in another clinical study in which the subject received an experimental or investigational drug agent within 3 months before screening.
- Risk of violent or destructive behavior.
- Current involuntary hospitalization or incarceration.
Sites / Locations
- Pillar Clinical Research
- Woodland International Research Group
- Advanced Research Center, Inc.
- Clinical Innovations, Inc
- ProScience Research Group
- Collaborative Neuroscience Research, LLC.
- CNS Network
- NRC Research Institute
- Artemis Institute for Clinical Research
- Behavioral Clinical Research, Inc.
- Larkin Behavioral Health Services
- Atlanta Center for Medical Research
- iResearch Atlanta, LLC
- AMITA Health Center for Psychiatric Research
- Uptown Research Institute
- AMITA Health Center for Psychiatric Research
- Hassman Research Institute
- Hassman Research Institute
- Community Clinical Research, Inc.
- InSite Clinical Research, LLC
- Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov
- Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine
- Regional Clinical Psychiatric Hospital No. 3, Adult Psychiatric Department No. 3
- Regional Clinical Psychiatric Hospital No. 3, Psychiatric Department for First Episode Psychosis
- Kherson Regional Institution of Mental Care
- Kyiv City Psychoneurological Hospital #2
- Kyiv Regional Medical Incorporation "Psychiatry", Center for Novel Treatment and Rehabilitation of Psychotic Disorders
- Lviv Regional Clinical Psychiatric Hospital, Department #20
- Lviv Regional Clinical Psychiatric Hospital, Department #25
- Regional Institution of Mental Psychiatric Care of the Poltava Regional Council
- Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council
- M.I. Pyrogov Vinnytsya National Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KarXT
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Secondary Outcome Measures
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5
The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For positive symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5
The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Marder Factor Score
The Negative Marder Factor score is derived from the PANSS and consists of the sum of 5 negative scales (N) and 2 general scales (G) (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance), with a minimum score of 7 and a maximum score of 49.
Clinical Global Impression - Severity (CGI-S) Score at Week 5
The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
Percentage of Positive and Negative Syndrome Scale (PANSS) responders (a 30% change in PANSS total score) at Week 5
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 5.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04738123
Brief Title
A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)
Official Title
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adults With DSM-5 Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
November 29, 2022 (Actual)
Study Completion Date
December 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karuna Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter inpatient study to examine the efficacy and safety of KarXT in adult subjects who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily [BID]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophrenia; Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KarXT
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Xanomeline and Trospium Chloride Capsules
Intervention Description
Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-35 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Capsules
Primary Outcome Measure Information:
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
Description
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time Frame
Week 5
Secondary Outcome Measure Information:
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5
Description
The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For positive symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time Frame
Week 5
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5
Description
The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time Frame
Week 5
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Marder Factor Score
Description
The Negative Marder Factor score is derived from the PANSS and consists of the sum of 5 negative scales (N) and 2 general scales (G) (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance), with a minimum score of 7 and a maximum score of 49.
Time Frame
Week 5
Title
Clinical Global Impression - Severity (CGI-S) Score at Week 5
Description
The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
Time Frame
Week 5
Title
Percentage of Positive and Negative Syndrome Scale (PANSS) responders (a 30% change in PANSS total score) at Week 5
Description
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 5.
Time Frame
Week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is aged 18 to 65 years, inclusive, at screening.
Subject is capable of providing informed consent.
A signed informed consent form must be provided before any study assessments are performed.
Subject must be fluent (oral and written) in English or local language to consent
Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2.
Subject is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening.
The subject requires hospitalization for this acute exacerbation or relapse of psychotic symptoms.
If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
Positive and Negative Syndrome Scale total score between 80 and 120, inclusive. Score of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items:
Item 1 (P1; delusions)
Item 2 (P2; conceptual disorganization)
Item 3 (P3; hallucinatory behavior)
Item 6 (P6; suspiciousness/persecution)
Subjects with no change (improvement) in PANSS total score between screening and baseline (Day -1) of more than 20%.
Subject has a CGI-S score of ≥4 at screening and baseline (Day -1) visits.
Subject will have been off lithium therapy for at least 2 weeks before baseline and free of all oral antipsychotic medications for at least 5 half-lives or 1 week, whichever is longer, before baseline (Day -1).
Subjects taking a long-acting injectable antipsychotic could not have received a dose of medication for at least 12 weeks (24 weeks for INVEGA TRINZA) before baseline visit (Day -1).
Subject is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
BMI must be ≥18 and ≤40 kg/m2.
Subject resides in a stable living situation and is anticipated to return to that same stable living situation after discharge, in the opinion of the investigator.
Subject has an identified reliable informant/caregiver.
Women of childbearing potential, or men with sexual partners of childbearing potential, must be able and willing to use at least 1 highly effective method of contraception during the study and for 30 days after the last dose of study drug. Sperm donation is not allowed for 30 days after the final dose of study drug.
Exclusion Criteria:
Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening). Symptoms of mild mood dysphoria or anxiety are allowed as long as these symptoms are not the primary focus of treatment. A screening subject with mild substance abuse disorder within the 12 months before screening must be discussed and agreed upon with the medical monitor before they can be allowed into the study.
Subjects who are newly diagnosed or are experiencing their first treated episode of schizophrenia.
History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
Subjects with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results.
History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS).
Clinically significant abnormal finding on the physical examination, medical history, ECG, or clinical laboratory results at screening.
Subjects cannot currently (within 5 half-lives or 1 week, whichever is longer, before baseline [Day -1]) be receiving oral antipsychotic medications; monoamine oxidase inhibitors; anticonvulsants (eg, lamotrigine, Depakote); tricyclic antidepressants (eg, imipramine, desipramine); selective serotonin reuptake inhibitors; or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam, chloral hydrate).
Pregnant, lactating, or less than 3 months postpartum.
If, in the opinion of the investigator (and/or Sponsor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator (and/or Sponsor), may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements.
Positive test for coronavirus (COVID-19) within 2 weeks before screening and at screening.
Subjects with extreme concerns relating to global pandemics, such as COVID-19, that preclude study participation.
Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening.
Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) or required clozapine within the last 12 months.
Subjects with prior exposure to KarXT.
Subjects who experienced any adverse effects due to xanomeline or trospium.
Participation in another clinical study in which the subject received an experimental or investigational drug agent within 3 months before screening.
Risk of violent or destructive behavior.
Current involuntary hospitalization or incarceration.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inder Kaul, MD
Organizational Affiliation
Karuna Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Pillar Clinical Research
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Clinical Innovations, Inc
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Collaborative Neuroscience Research, LLC.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
CNS Network
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Behavioral Clinical Research, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Larkin Behavioral Health Services
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
AMITA Health Center for Psychiatric Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
Facility Name
Uptown Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
AMITA Health Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
InSite Clinical Research, LLC
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Regional Clinical Psychiatric Hospital No. 3, Adult Psychiatric Department No. 3
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Regional Clinical Psychiatric Hospital No. 3, Psychiatric Department for First Episode Psychosis
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kherson Regional Institution of Mental Care
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Kyiv City Psychoneurological Hospital #2
City
Kyiv
ZIP/Postal Code
02192
Country
Ukraine
Facility Name
Kyiv Regional Medical Incorporation "Psychiatry", Center for Novel Treatment and Rehabilitation of Psychotic Disorders
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Lviv Regional Clinical Psychiatric Hospital, Department #20
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Lviv Regional Clinical Psychiatric Hospital, Department #25
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Regional Institution of Mental Psychiatric Care of the Poltava Regional Council
City
Poltava
ZIP/Postal Code
36013
Country
Ukraine
Facility Name
Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council
City
Smila
ZIP/Postal Code
20708
Country
Ukraine
Facility Name
M.I. Pyrogov Vinnytsya National Medical University
City
Vinnytsya
ZIP/Postal Code
21037
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)
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