SchizophreniaPhase 2EMERGENT-1NCT03697252
A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
A Phase 2 study testing Xanomeline and Trospium Chloride Capsules in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 12 sites in United States.
Trial summary
This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Xanomeline and Trospium Chloride Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 12 sitesUnited States
- Study dates
- 18 Sep 2018to 4 Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject is aged 18-60 years, inclusive, at screening
- Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) 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 symptoms, with onset less than 2 months before screening
- Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening
- Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening:
- Item 1 (P1; delusions)
Show all 18Show fewer
- Item 2 (P2; conceptual disorganization)
- Item 3 (P3; hallucinatory behavior)
- Item 6 (P6; suspiciousness/persecution)
- There should not be a change (improvement) in PANSS total score between screening and baseline of more than 20%
- Subjects taking a depot antipsychotic could not have received a dose of medication for at least 1 and a half injection cycles before baseline (eg, 3 or more weeks off for a 2-week cycle)
- Subject is capable of providing informed consent
- A signed ICF must be provided before any study assessments are performed
- Subject must be fluent (oral and written) in English in order to consent
- Subject must have CGI-S score of ≥ 4 at screening and baseline visits
- Body mass index must be ≥ 18 and ≤ 40 kg/m2
- Both females of child bearing potential and males with partners of child bearing potential must be willing to use a double-barrier method of birth control (ie, any double combination of male or female condom with spermicidal gel, diaphragm, sponge, or cervical cap with spermicidal gel) during the study and for 7 days after the last dose of study drug.
- Subject has an identified reliable informant
Who cannot join
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening)
- 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, to exclude patients with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the liver function test results.
- History of 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
- Has a DSM-5 diagnosis of moderate to severe substance abuse disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current abuse as determined by urine toxicology screen or alcohol test. 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 he/she can be allowed into the study.
- Clinically significant abnormal finding on the physical examination, medical history, ECG, or clinical laboratory results at screening
Show all 13Show fewer
- Pregnant, lactating, or less than 3 months postpartum. Sperm donation is not allowed for 90 days after the final dose of study drug
- 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 their ability to adhere to the protocol visit schedule or fulfill visit requirements
- 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
- Risk of violent or destructive behavior
- Current involuntary hospitalization or incarceration
- Participation in another clinical study in which the subject received an experimental or investigational drug agent within 3 months of screening
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Community Clinical Research, Inc.
Austin, Texas, 78754
Hassman Research Institute
Berlin, New Jersey, 08009
Midwest Clinical Research Center (and IP Shipment)
Dayton, Ohio, 45417
InSite Clinical Research, LLC
DeSoto, Texas, 75115
CBH Health, LLC
Gaithersburg, Maryland, 20877
Synergy East
Lemon Grove, California, 91945
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806
NRC Research Institute
Orange, California, 92868
Pillar Clinical Research, LLC
Richardson, Texas, 75080
Artemis Institute for Clinical Research
San Diego, California, 92103
About this study
Official title: A Phase 2, Randomized, Double-blinded Study to Assess the Safety, Tolerability, and Efficacy of KarXT in Hospitalized Adults With DSM-5 Schizophrenia
This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline and trospium chloride) (xanomeline 125 mg/trospium 30 mg twice daily [BID]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a Diagnostic and Statistical Manual-Fifth Edition (DSM-5) diagnosis of schizophrenia. The secondary objectives of the study are to assess overall safety and tolerability of KarXT in adult inpatients with a DSM-5 diagnosis of schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Xanomeline and Trospium Chloride Capsules, Placebo Capsules
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanomeline and Trospium Chloride CapsulesDrug
Also called KarXT
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 8-34 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. Dosing must not change after Visit 7 of the study (at 21 ± 2 days of dosing) and may be decreased for tolerability reasons no more than once during the study.
Placebo CapsulesDrug
Placebo Capsules
| Study group | Role | What they receive |
|---|---|---|
| KarXT | Experimental | Not described Receives: Drug: Xanomeline and Trospium Chloride Capsules |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 were 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.
Measured: Baseline and Week 5
Secondary outcomes (5)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive 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. The positive symptoms in schizophrenia are the excess or distortion of normal functions such as hallucinations, delusions, grandiosity, and hostility. Participants were 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.
Measured: Baseline and Week 5
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
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.
Measured: Baseline and Week 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative 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. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Participants were 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.
Measured: Baseline and Week 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Score
The Marder Negative 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.
Measured: Baseline and Week 5
Percentage of Participants Who Were Clinical Global Impression - Severity of Illness (CGI-S) Responders
The CGI-S modified asks the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer was 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. A CGI-S responder is defined as a participant with a CGI-S scale equal to 1 or 2.
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start18 Sep 2018
- Primary completion4 Sep 2019
- Study completion4 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Brannan, MD, Study director, Karuna Therapeutics, Inc., a Bristol Myers Squibb company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697252
- Sponsor's protocol ID
- KAR-004
- Acronym
- EMERGENT-1
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2018
- Last updated
- 26 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeung PP, Breier A, Zhu H, Kaul I, Marcus RN. Xanomeline and Trospium Chloride for the Treatment of Agitation Associated With Schizophrenia: PANSS-Excited Component Results From 3 Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials. J Clin Psychiatry. 2025 Mar 24;86(2):24m15668. doi: 10.4088/JCP.24m15668.
PubMed 40215379Citrome L, Neugebauer NM, Meli AA, Kando J. Xanomeline and Trospium Chloride Versus Placebo for the Treatment of Schizophrenia: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. Neuropsychiatr Dis Treat. 2025 Apr 5;21:761-773. doi: 10.2147/NDT.S503494. eCollection 2025.
PubMed 40212458Ramey OL, Silva Almodovar A. Xanomeline-Trospium: A Novel Therapeutic for the Treatment of Schizophrenia. Ann Pharmacother. 2025 Oct;59(10):937-950. doi: 10.1177/10600280251324642. Epub 2025 Mar 27.
PubMed 40145363Kaul I, Claxton A, Sawchak S, Sauder C, Brannan SK, Raj E, Ruan S, Konis G, Brown D, Cutler AJ, Marcus R. Safety and Tolerability of Xanomeline and Trospium Chloride in Schizophrenia: Pooled Results From the 5-Week, Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials. J Clin Psychiatry. 2025 Feb 26;86(1):24m15497. doi: 10.4088/JCP.24m15497.
PubMed 40047530Sauder C, Allen LA, Baker E, Miller AC, Paul SM, Brannan SK. Effectiveness of KarXT (xanomeline-trospium) for cognitive impairment in schizophrenia: post hoc analyses from a randomised, double-blind, placebo-controlled phase 2 study. Transl Psychiatry. 2022 Nov 21;12(1):491. doi: 10.1038/s41398-022-02254-9.
PubMed 36414626Weiden PJ, Breier A, Kavanagh S, Miller AC, Brannan SK, Paul SM. Antipsychotic Efficacy of KarXT (Xanomeline-Trospium): Post Hoc Analysis of Positive and Negative Syndrome Scale Categorical Response Rates, Time Course of Response, and Symptom Domains of Response in a Phase 2 Study. J Clin Psychiatry. 2022 May 11;83(3):21m14316. doi: 10.4088/JCP.21m14316.
PubMed 35552528Targum SD, Murphy C, Breier A, Brannan SK. Site-independent confirmation of primary site-based PANSS ratings in a schizophrenia trial. J Psychiatr Res. 2021 Dec;144:241-246. doi: 10.1016/j.jpsychires.2021.10.027. Epub 2021 Oct 21.
PubMed 34700212Brannan SK, Sawchak S, Miller AC, Lieberman JA, Paul SM, Breier A. Muscarinic Cholinergic Receptor Agonist and Peripheral Antagonist for Schizophrenia. N Engl J Med. 2021 Feb 25;384(8):717-726. doi: 10.1056/NEJMoa2017015.
PubMed 33626254
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blinded Study to Assess the Safety, Tolerability, and Efficacy of KarXT in Hospitalized Adults With DSM-5 Schizophrenia
- ClinicalTrials.gov ID
- NCT03697252
- Acronym / sponsor ID
- EMERGENT-1 / KAR-004
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb companyIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Posted 28 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline and trospium chloride) (xanomeline 125 mg/trospium 30 mg twice daily [BID]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a Diagnostic and Statistical Manual-Fifth Edition (DSM-5) diagnosis of schizophrenia. The secondary objectives of the study are to assess overall safety and tolerability of KarXT in adult inpatients with a DSM-5 diagnosis of schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KarXT | Experimental | Drug: Xanomeline and Trospium Chloride Capsules |
| Placebo | Placebo comparator | Drug: Placebo Capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Subject is aged 18-60 years, inclusive, at screening
- Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) 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 symptoms, with onset less than 2 months before screening
- Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening
- There should not be a change (improvement) in PANSS total score between screening and baseline of more than 20%
Key exclusion criteria (13 listed)
- Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening)
- 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, to exclude patients with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the liver function test results.
- History of 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
- Has a DSM-5 diagnosis of moderate to severe substance abuse disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current abuse as determined by urine toxicology screen or alcohol test. 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 he/she can be allowed into the study.
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 |
|---|---|---|
| Xanomeline and Trospium Chloride CapsulesAlso: KarXTXanomeline 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 8-34 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. Dosing must not change after Visit 7 of the study (at 21 ± 2 days of dosing) and may be decreased for tolerability reasons no more than once during the study. | Drug | KarXT |
| Placebo CapsulesPlacebo Capsules | Drug | Placebo |
Primary outcome
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
Time frame: Baseline and 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 were 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.
5 secondary outcomes
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5
Time frame: Baseline and Week 5
Number of Participants With Each Clinical Global Impression - Severity (CGI-S) Score at Baseline and 5 Weeks
Time frame: Baseline and Week 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5
Time frame: Baseline and Week 5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Score
Time frame: Baseline and Week 5
Percentage of Participants Who Were Clinical Global Impression - Severity of Illness (CGI-S) Responders
Time frame: Week 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40215379Yeung PP, Breier A, Zhu H, Kaul I, Marcus RN. Xanomeline and Trospium Chloride for the Treatment of Agitation Associated With Schizophrenia: PANSS-Excited Component Results From 3 Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials. J Clin Psychiatry. 2025 Mar 24;86(2):24m15668. doi: 10.4088/JCP.24m15668.
- Derived from this study: PubMed 40212458Citrome L, Neugebauer NM, Meli AA, Kando J. Xanomeline and Trospium Chloride Versus Placebo for the Treatment of Schizophrenia: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. Neuropsychiatr Dis Treat. 2025 Apr 5;21:761-773. doi: 10.2147/NDT.S503494. eCollection 2025.
- Derived from this study: PubMed 40145363Ramey OL, Silva Almodovar A. Xanomeline-Trospium: A Novel Therapeutic for the Treatment of Schizophrenia. Ann Pharmacother. 2025 Oct;59(10):937-950. doi: 10.1177/10600280251324642. Epub 2025 Mar 27.
- Derived from this study: PubMed 40047530Kaul I, Claxton A, Sawchak S, Sauder C, Brannan SK, Raj E, Ruan S, Konis G, Brown D, Cutler AJ, Marcus R. Safety and Tolerability of Xanomeline and Trospium Chloride in Schizophrenia: Pooled Results From the 5-Week, Randomized, Double-Blind, Placebo-Controlled EMERGENT Trials. J Clin Psychiatry. 2025 Feb 26;86(1):24m15497. doi: 10.4088/JCP.24m15497.
- Derived from this study: PubMed 36414626Sauder C, Allen LA, Baker E, Miller AC, Paul SM, Brannan SK. Effectiveness of KarXT (xanomeline-trospium) for cognitive impairment in schizophrenia: post hoc analyses from a randomised, double-blind, placebo-controlled phase 2 study. Transl Psychiatry. 2022 Nov 21;12(1):491. doi: 10.1038/s41398-022-02254-9.
- Derived from this study: PubMed 35552528Weiden PJ, Breier A, Kavanagh S, Miller AC, Brannan SK, Paul SM. Antipsychotic Efficacy of KarXT (Xanomeline-Trospium): Post Hoc Analysis of Positive and Negative Syndrome Scale Categorical Response Rates, Time Course of Response, and Symptom Domains of Response in a Phase 2 Study. J Clin Psychiatry. 2022 May 11;83(3):21m14316. doi: 10.4088/JCP.21m14316.
- Derived from this study: PubMed 34700212Targum SD, Murphy C, Breier A, Brannan SK. Site-independent confirmation of primary site-based PANSS ratings in a schizophrenia trial. J Psychiatr Res. 2021 Dec;144:241-246. doi: 10.1016/j.jpsychires.2021.10.027. Epub 2021 Oct 21.
- Derived from this study: PubMed 33626254Brannan SK, Sawchak S, Miller AC, Lieberman JA, Paul SM, Breier A. Muscarinic Cholinergic Receptor Agonist and Peripheral Antagonist for Schizophrenia. N Engl J Med. 2021 Feb 25;384(8):717-726. doi: 10.1056/NEJMoa2017015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Brannan, MD study director
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xanomeline and Trospium Chloride Capsules in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5 (time frame: Baseline and Week 5). 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 NCT03697252, which also lists 8 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 26 Oct 2020.