AzTrials
AzTrials

SchizophreniaPhase 3ARISENCT05145413

A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

A Phase 3 study testing Xanomeline and Trospium Chloride Capsules in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 166 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with schizophrenia with an inadequate response to their current atypical antipsychotic treatment. Read more about this study

Who is it for?
Ages 18 to 65 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
396 participants
Where
166 sitesin 8 countries
Study dates
12 Nov 2021to 19 Mar 2025
Phase
Phase 3
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is aged ≥18 to <65 years at the time of randomization
  • Subject is capable of providing signed Informed Consent Form before any study assessments will be performed
  • 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 currently being treated with stable dosing of monotherapy risperidone, paliperidone, aripiprazole, or their LAIs ziprasidone, lurasidone, or cariprazine and has been taking this treatment with the same dosing regimen for at least 8 weeks at the time of Day 1 (Visit 3)
  • The subject has had at least 1 previous inadequate response to above antipsychotics that was dosed appropriately (within the label) for at least 6 weeks
  • The subject has not required psychiatric hospitalization, incarceration in prison, acute crisis intervention, or other increase in the level of care due to symptom exacerbation within 8 weeks of Screening and is psychiatrically stable in the opinion of the Investigator
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  • To be eligible for randomization, subjects need to have detectable levels of background antipsychotic medication (measured at Visit 1)
  • Positive and Negative Syndrome Scale (PANSS) total score ≥ 70 at Screening and randomization
  • Clinical Global Impression-Severity (CGI-S) scale with a score ≥ 4 (moderate) at Screening and randomization
  • PANSS Marder Positive symptom factor ≥ 4 on 2 (or more) items (PANSS items, delusions, hallucinations, grandiosity, suspiciousness and persecution, stereotyped thinking, somatic concern, unusual thought content or lack of judgment and insight), at Screening and randomization
  • Subjects with ≤ 20-point decrease in PANSS Total score between Visit 1 and Visit 3
  • Subject is willing and able to visit the clinic in an outpatient setting for the study duration, follow instructions, and comply with the protocol requirements
  • Body Mass Index (BMI) must be within 18 to 40 kg/m2 (inclusive of both values)
  • Subject resides in a stable living situation in the opinion of the Investigator
  • Subject has identified a reliable informant/ caregiver willing and able to assist with study activities as needed throughout the subject's participation in the study. The informant needs to be physically present at the Baseline visit, but can complete the remaining study visits assessments via phone (as needed and as per local regulations). In Bulgaria, the informant needs to physically present at the Baseline visit and should be physically present at all study visits where the Investigator determines that his/her input would be beneficial.
  • Women of childbearing potential (WOCP), or men whose sexual partners are WOCP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of study drug. Sperm donation is not allowed for 30 days after the final dose of the study drug. A female subject is considered to be a WOCP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)

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)
  • The subject has a history of moderate to severe substance use disorder (other than nicotine) within the past 12 months
  • A Screening subject with mild substance use disorder within the 12 months before Screening must be discussed with the Medical Monitor before being allowed into the study
  • Subjects who test positive for cannabis at Screening may be permitted to enroll in consultation with the Medical Monitor if the subject's pattern of use is not indicative of a moderate to severe substance use disorder
  • Subject has a history of treatment-resistant schizophrenia defined as:
  • Failure to minimally respond to 2 adequate courses of antipsychotic drug (APD) pharmacotherapy Note: Failure to minimally respond is defined as persistence symptoms of moderate severity in 2 or more psychotic symptom domains or persistence of severe symptoms in 1 or more psychotic symptom domains despite adequate dose and duration (6 weeks or longer) of APD treatment.
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  • History of symptom instability
  • > 3 psychiatric hospitalizations over the last 12 months or 2 over the last 6 months
  • Current APD is other than aripiprazole, risperidone, paliperidone, or their LAI versions, ziprasidone, lurasidone, or cariprazine
  • Subjects who are diagnosed with schizophreniform disorder or are experiencing their first treated episode of schizophrenia
  • Significant or severe medical conditions including pulmonary, cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject or the validity of the study results
  • eGFR < 60 mL/min
  • Alanine transaminase or aspartate transaminase (AST) > 1.5 x upper limit of normal (ULN)
  • Total bilirubin > 1.5 x ULN (Subjects with Gilbert's syndrome can be included as long as direct bilirubin is ≤ 1.5 x ULN)
  • Subjects with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history, serologies or LFT results
  • History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator
  • History of irritable bowel syndrome (with or without constipation) or any 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/or C-SSRS as confirmed by the following:
  • Answers "Yes" on items 4 or 5 (C-SSRS - ideation) with the most recent episode occurring within the 2 months before Screening or,
  • Answers "Yes" to any of the 5 items (C-SSRS behavior) with an episode occurring within the 12 months before Screening
  • Clinically significant abnormal finding on the physical examination, medical history, ECG, or clinical laboratory results at Screening
  • Urine toxicology screen is positive for phencyclidine, amphetamines, opiates, cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator)
  • Subject is currently taking, or plans to take while in the study, any prohibited concomitant medication.
  • Pregnant, lactating, or less than 3 months postpartum
  • If, in the opinion of the Investigator and/or Sponsor/Medical Monitor subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator and/or Sponsor/Medical Monitor, 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 or at Screening
  • Subjects with extreme concerns relating to global pandemics, such as COVID-19, that would obscure ratings or be expected to disrupt adherence to trial procedures
  • Unable to taper and discontinue a concomitant medication that would preclude participation in the double-blind adjunctive treatment (e.g., cannot stop anticholinergic)
  • Subjects with prior exposure to KarXT
  • Subjects who experienced any adverse effects due to xanomeline or trospium
  • Subjects who received investigational product as part of a clinical trial within 3 months of Screening
  • Risk of violent or destructive behavior as per Investigator's judgment that would interfere with subject's participation
  • Current involuntary hospitalization or incarcerationor on parole/probation
  • For all male subjects only, any one of the following:
  • History of bladder stones
  • History of recurrent urinary tract infections
  • Serum prostate specific antigen (PSA) >10 ng/mL
  • An International Prostate Symptom Score (IPSS) of 5 (almost always) on either item 1, 3, 5, or 6
  • A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9 Note: IPSS will be required only for male subjects ≥ 45 years of age. Subjects already enrolled in the study will have these assessments at their next clinic visit planned after re-consenting to determine current eligibility.

Trial locations and contacts

166 sites in 8 countries.

166 sites in 8 countries

United States79 sites

  • Advanced Research Center, Inc.

    Anaheim, California, 92805

  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan, 48105

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Synexus Clinical Research US, Inc.

    Atlanta, Georgia, 30328

  • Local Institution - 192

    Atlanta, Georgia, 30331

  • Local Institution - 135

    Augusta, Georgia, 30912

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • CITrials - Bellflower

    Bellflower, California, 90706-7079

  • CenExel Hassman Research Institute

    Berlin, New Jersey, 08009

  • Local Institution - 158

    Boston, Massachusetts, 02114

  • Local Institution - 187

    Boston, Massachusetts, 02118

  • Synexus Clinical Research US, Inc.

    Cerritos, California, 90703

  • Northwestern University

    Chicago, Illinois, 60611

  • American Medical Research, Inc.

    Chicago, Illinois, 60612-2307

  • Uptown Research Institute, LLC

    Chicago, Illinois, 60640

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Local Institution - 186

    Coral Gables, Florida, 33134

  • Clinical Innovations Inc.

    Costa Mesa, California, 92626

  • Proscience Research Group

    Culver City, California, 90230

  • CenExel iResearch Atlanta

    Decatur, Georgia, 30030

  • InSite Clinical Research; LLC

    DeSoto, Texas, 75115

  • Prevention Science Institute

    Eugene, Oregon, 97403

  • JPS Health Network

    Fort Worth, Texas, 76104

  • CenExel Center for Behavioral Health

    Gaithersburg, Maryland, 20877

  • CenExel Collaborative Neuroscience Research

    Garden Grove, California, 92845

  • Local Institution - 168

    Garfield Heights, Ohio, 44125

  • Cherry Health

    Grand Rapids, Michigan, 49548-6927

  • Reliable Clinical Research LLC

    Hialeah, Florida, 33012

  • Galiz Research, LLC

    Hialeah, Florida, 33016-1814

  • Clinical Trials of America - Psychiatry

    Hickory, North Carolina, 28601

  • Ben Taub Hospital

    Houston, Texas, 77030

  • Clinical Trial Network LLC

    Houston, Texas, 77074

  • Insight Clinical Trials LLC

    Independence, Ohio, 44131

  • University Hills Clinical Research - Irving

    Irving, Texas, 75062

  • Western Michigan University Homer Stryker M.D. School of Medicine

    Kalamazoo, Michigan, 49001

  • Omega Clinical Trials

    La Habra, California, 90631

  • Sunwise Clinical Research, LLC.

    Lafayette, California, 94549

  • Altea Research Institute, Las Vegas

    Las Vegas, Nevada, 89102

  • Adaptive Clinical Research, Inc

    Lauderhill, Florida, 33319-4985

  • Synergy Clinical Research of Escondido

    Lemon Grove, California, 91945

  • Pillar Clinical Research, LLC

    Little Rock, Arkansas, 72204

  • Woodland International Research Group, LLC

    Little Rock, Arkansas, 72211

  • Encino Hospital Medical Center

    Los Angeles, California, 91403

  • Psych Atlanta, P.C.

    Marietta, Georgia, 30060

  • Behavioral Clinical Research , Inc

    Miami, Florida, 33016

  • Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • Assertive Research Center

    Miami Lakes, Florida, 33016

  • Envision Trials LLC

    Miami Springs, Florida, 33166

  • IMA Clinical Research

    Monroe, Louisiana, 71201-2986

  • Synexus Clinical Research US, Inc.

    New York, New York, 10017

  • Manhattan Psychiatric Center

    New York, New York, 10027

  • Manhattan Behavioral Medicine, PLLC

    New York, New York, 10036

  • Excell Research, Inc.

    Oceanside, California, 92056

  • The Rivus Wellness & Research Institute

    Oklahoma City, Oklahoma, 73112

  • Omaha Insomnia and Psychiatric Services LLC

    Omaha, Nebraska, 68144

  • Neuropsychiatric Research Center of Orange County

    Orange, California, 92868

  • Local Institution - 124

    Orange City, Florida, 32763

  • Pines Care Research Center, Inc.

    Pembroke Pines, Florida, 33024

  • IMA Clinical Research

    Phoenix, Arizona, 85012

  • Local Institution - 147

    Phoenix, Arizona, 85012

  • CNRI - Los Angeles, LLC

    Pico Rivera, California, 90660

  • Phoenix Medical Research, Inc.

    Prairie Village, Kansas, 66208

  • Pillar Clinical Research, LLC

    Richardson, Texas, 75080

  • At Health Texas

    Richmond, Texas, 77407

  • Perceptive Pharma Research

    Richmond, Texas, 77407

  • CenExel Clinical Innovations, Inc.

    Riverside, California, 92506

  • Psychiatry and Alzheimer's Care of Rochester. PLLC

    Rochester, New York, 14623

  • Green Mountain Research Institute

    Rutland, Vermont, 05701

  • Cnri-San Diego

    San Diego, California, 92123

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405

  • Local Institution - 129

    St Louis, Missouri, 63128

  • Arch Clinical Trials LLC

    St Louis, Missouri, 63141

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Richmond Behavioral Associates ERG Clinical Research - New York PLLC

    Staten Island, New York, 10314

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida, 33629

  • CenExel Collaborative Neuroscience Research

    Torrance, California, 90504

  • Local Institution - 185

    Worcester, Massachusetts, 01655

Other trials in United States

Bulgaria21 sites

  • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov

    Cherven Bryag, 5980

  • Medical Centre 'Asklepii', OOD

    Dupnitsa, 2600

  • Medical Center Lifemed

    Kardzhali, 6600

  • MHAT Dr. Hristo Stambolski, EOOD

    Kazanlak, Stara Zagora, 6100

  • State Psychiatric Hospital 'Sv. Ivan Rilski', Novi Iskar

    Novi Iskar, 1282

  • Medical Center Medconsult Pleven OOD

    Pleven, 5800

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • UMHAT Sv. Georgi, EAD

    Plovdiv, 4002

  • Local Institution - 321

    Plovdiv, 4004

  • Local Institution - 313

    Razgrad, 7200

  • MHAT Dr Ivan Seliminski AD

    Sliven, 8800

  • Medical Center 'Sv.Naum'

    Sofia, 1113

  • MHC - Sofia, EOOD

    Sofia, 1202

  • Local Institution - 320

    Sofia, 1407

  • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

    Sofia, 1408

  • Medical Center Akademika EOOD

    Sofia, 1431

  • Medical Center Hera EOOD

    Sofia, 1510

  • Medical Center Intermedica, OOD

    Sofia, 1680

  • Medical Center VAS OOD

    Targovishte, 7700

  • DCC Mladost M - Varna, OOD

    Varna, 9020

  • Mental Health Center-Vratsa EOOD

    Vratsa, 3000

Other trials in Bulgaria

India19 sites

  • Local Institution - 607

    Ahmedabad, Gujarat, 380008

  • Local Institution - 604

    Ahmedabad, Gujarat, 380013

  • Local Institution - 615

    Ajmer, Rajasthan, 305001

  • Local Institution - 617

    Belgavi, Karnataka, 590001

  • Local Institution - 618

    Bikaner, Rajasthan, 334003

  • Local Institution - 610

    Chhatrapati Sambhajinagar, Maharashtra, 431005

  • Local Institution - 616

    Guwahati, Assam, 781032

  • Local Institution - 611

    Kozhikode, Kerala, 673009

  • Local Institution - 612

    Lucknow, Uttar Pradesh, 226003

  • Local Institution - 614

    Mangalore, Karnataka, 575003

  • Local Institution - 602

    Mangalore, Karnataka, 575018

  • Local Institution - 619

    Mumbai, Maharashtra, 400008

  • Local Institution - 601

    Mysore, Karnataka, 570001

  • Local Institution - 603

    Nagpur, Maharashtra, 440010

  • Local Institution - 608

    Nashik, Maharashtra, 422001

  • Local Institution - 605

    Nashik, Maharashtra, 422005

  • Local Institution - 606

    Rajkot, Rajasthan, 360001

  • Local Institution - 609

    Surat, Gujarat, 395001

  • Local Institution - 613

    Vadodara, Gujarat, 390021

Other trials in India

Serbia12 sites

  • Clinical Center ' Dr Dragisa Misovic Dedinje'

    Belgrade, 11000

  • Institute of Mental Health

    Belgrade, 11000

  • Local Institution - 413

    Belgrade, 11000

  • Local Institution - 417

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • "Special Hospital for Psychiatric Diseases ""Kovin"""

    Kovin, 26220

  • Special Hospital for Psychiatric Diseases 'Kovin'

    Kovin, 26220

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • University Clinical Center Nis

    Niš, 18000

  • Special Hospital for Psychiatric Diseases 'Gornja Toponica'

    Niš, 18202

  • Special Hospital for Psychiatric Diseases 'Sveti Vracevi'

    Novi Kneževac, 23330

  • Special Hospital for Psychiatric Disease 'Dr Slavoljub Bakalovic'

    Vršac, 26300

Other trials in Serbia

Romania10 sites

  • Local Institution - 803

    Brasov, 500123

  • Local Institution - 809

    Bucharest, 041914

  • Local Institution - 804

    Bucharest, 10825

  • Local Institution - 810

    Bucharest, 40874

  • Local Institution - 802

    Bucharest, 41914

  • Local Institution - 807

    Bucharest, 60222

  • Local Institution - 808

    Craiova, 200157

  • Local Institution - 801

    Galati, 800179

  • Local Institution - 806

    Iași, 700282

  • Local Institution - 805

    Sibiu, 550281

Other trials in Romania

United Kingdom10 sites

  • Local Institution - 706

    Ashton-under-Lyne, Greater Manchester, OL6 7SR

  • Local Institution - 703

    Birmingham, West Midlands, B4 6NH

  • Local Institution - 705

    Brighton, East Sussex, BN1 9RY

  • Local Institution - 702

    Chertsey, Surrey, KT16 9AU

  • Local Institution - 704

    Glasgow, Strathclyde, G51 4TF

  • Local Institution - 701

    London, Greater London, SE5 8AF

  • Local Institution - 709

    Maidstone, Kent, ME16 9PH

  • Local Institution - 710

    Manchester, Greater Manchester, M8 5RB

  • Local Institution - 708

    Oxford, Oxfordshire, OX3 7JX

  • Local Institution - 707

    Pool, Reruth, Cornwall, TR15 3QE

Other trials in United Kingdom

Poland9 sites

  • Local Institution - 506

    Bialystok, 15-404

  • Local Institution - 507

    Gdansk, 80-546

  • Local Institution - 509

    Grudziądz, 86-300

  • Local Institution - 501

    Kielce, 25-411

  • Local Institution - 503

    Lodz, 90-227

  • Local Institution - 505

    Lublin, 20-109

  • Local Institution - 502

    Siemianowice Śląskie, 41-100

  • Local Institution - 508

    Suchy Las, 62-002

  • Local Institution - 504

    Tuszyn, 95-080

Other trials in Poland

Japan6 sites

  • Local Institution - 255

    Fukuoka, 819-0037

  • Local Institution - 254

    Karatsu-shi, Saga-ken, 847-0031

  • Local Institution - 258

    Kōnan, Aichi-ken, 483-8248

  • Local Institution - 257

    Shirakawa, Fukushima, 961-0021

  • Local Institution - 256

    Tokyo, 162-0843

  • Local Institution - 250

    Toyoake-shi, Aichi-ken, 470-1168

Other trials in Japan

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

This is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with schizophrenia with an inadequate response to their current atypical antipsychotic treatment. The primary objective of the study is to assess the efficacy of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily [BID]) versus placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.

Conditions
Schizophrenia
Being tested
Xanomeline and Trospium Chloride Capsules, Placebo
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

    KarXT 50 mg/20 mg BID KarXT 75mg/20 mg BID KarXT 100mg/20 mg BID KarXT 125mg/30 mg BID

  • PlaceboDrug

    Placebo Capsules

Study groups in NCT05145413
Study groupRoleWhat they receive
Drug: KarXTExperimentalNot described
Receives: Drug: Xanomeline and Trospium Chloride Capsules
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6

    PANSS Total Score is a clinician administered measure of schizophrenia symptom severity used widely in antipsychotic research. It includes 30 items across 3 subscales:

    • Positive Symptoms (7 items) assessing excesses or distortions such as hallucinations, delusions, or grandiosity
    • Negative Symptoms (7 items) assessing diminished function such as social withdrawal or reduced motivation and
    • General Psychopathology (16 items) capturing broader symptoms like anxiety, depression, guilt, or cognitive impairment Each item is scored from 1 (absent) to 7 (extreme), producing a PANSS Total Score ranging from 30 to 210, with higher scores indicating more severe symptoms.

    Baseline is defined as the last non missing PANSS Total Score before first dose.

    This endpoint evaluates change from Baseline to Week 6, with negative values indicating improvement.

    Measured: Baseline to Week 6

Secondary outcomes (6)

  1. Change From Baseline in Personal and Social Performance Scale (PSP) at Week 6

    The Personal and Social Performance (PSP) Scale is a clinician administered assessment of personal and social functioning in individuals with schizophrenia. It evaluates functioning across four key dimensions:

    • Socially useful activities
    • Personal and social relationships
    • Self care and
    • Disturbing and aggressive behaviors The PSP is completed through a structured clinical interview and provides a total score ranging from 1 to 100, using a 6 point severity rating for each domain. Higher PSP scores indicate better personal and social functioning.

    The endpoint measures change from Baseline to Week 6 in PSP score, with positive values indicating improved personal and social functioning.

    Measured: Baseline to Week 6

  2. Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) at Week 6

    Change from baseline in the Clinical Global Impression-Severity (CGI-S) assesses change in overall illness severity over time as rated by the clinician. The CGI-S is a clinician-rated, single-item scale that evaluates the severity of the participant's illness at the time of assessment based on the clinician's total clinical experience with patients with the same diagnosis. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill), with higher scores indicating greater illness severity (worse outcome). Ratings are based on observed and reported symptoms, behavior, and functioning over the previous 7 days. Change from baseline is calculated as the difference between the CGI-S score at baseline and Week 6, with negative values indicating improvement and positive values indicating worsening.

    Measured: Baseline to Week 6

  3. Change From Baseline in Positive and Negative Syndrome Scale Marder Positive (PANSS M-Pos) Symptom Factor Score at Week 6

    Change from baseline in PANSS M-Pos Symptom Factor Score assesses change in the severity of positive symptoms of schizophrenia over time as rated by the clinician. The PANSS is a clinician-administered scale that evaluates symptom severity based on observed and reported symptoms. The PANSS Marder Positive Symptom Factor score is derived from the following PANSS items: Delusions (P1), Hallucinations (P3), Grandiosity (P5), Suspiciousness/Persecution (P6), Stereotyped Thinking (N7), Somatic Concern (G1), Unusual Thought Content (G9), and Lack of Judgment and Insight (G12). Each item is rated on a 7-point scale (1 = absent to 7 = extreme). The PANSS M-Pos factor score is calculated by summing the relevant item scores, with higher scores indicating greater positive symptom severity (worse outcome). Change from baseline is calculated as the difference between the PANSS M-Pos score at baseline and Week 6, with negative values indicating improvement and positive values indicating worsening.

    Measured: Baseline to Week 6

  4. Change From Baseline in Positive and Negative Syndrome Scale Marder Negative (PANSS M-Neg) Symptom Factor Score at Week 6

    Change from baseline in PANSS M-Neg Symptom Factor Score assesses change in the severity of negative symptoms of schizophrenia over time as rated by the clinician. The PANSS is a clinician-administered scale that evaluates symptom severity based on observed and reported symptoms. The PANSS Marder Negative Symptom Factor score is derived from the following PANSS items: Blunted Affect (N1), Emotional Withdrawal (N2), Poor Rapport (N3), Passive Social Withdrawal (N4), Lack of Spontaneity of Conversation (N6), Motor Retardation (G7), and Active Social Avoidance (G16). Each item is rated on a 7-point scale (1 = absent to 7 = extreme). The PANSS M-Neg factor score is calculated by summing the relevant item scores, with higher scores indicating greater negative symptom severity (worse outcome). Change from baseline is calculated as the difference between the PANSS M-Neg score at baseline and Week 6, with negative values indicating improvement and positive values indicating worsening.

    Measured: Baseline to Week 6

  5. Percentage of Participants Achieving a ≥ 30% Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6

    The Positive and Negative Syndrome Scale (PANSS) is a clinician administered scale that assesses symptom severity in schizophrenia and includes 30 items across three subscales: 7 positive symptoms, 7 negative symptoms, and 16 general psychopathology symptoms. Each item is scored from 1 (absent) to 7 (extreme), generating a PANSS Total Score ranging from 30 to 210, with higher scores indicating more severe symptoms. This endpoint evaluates the percentage of participants whose Week 6 PANSS Total Score decreased by at least 30% from Baseline, reflecting clinically meaningful improvement.

    Measured: At Week 6

  6. Percentage of Participants With Preference of Medication (POM) at Week 6

    The Preference of Medication (POM) is a two item questionnaire assessing the participant's and informant's preference for the current antipsychotic compared with the most recent pre study antipsychotic. It evaluates perceived benefit or worsening relative to prior treatment. The POM uses a 5 point scale: 1 = "much better, I prefer this medication," 2 = "slightly better," 3 = "about the same," 4 = "slightly worse," 5 = "much worse, I much prefer my previous medication." Based on this scale, responses are categorized as Better (scores 1-2) or Same or Worse (scores 3-5) for both participant and informant assessments.

    Measured: At Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2021
  2. Study start12 Nov 2021
  3. Primary completion19 Mar 2025
  4. Study completion19 Mar 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05145413
Sponsor's protocol ID
CN012-0008
Other IDs
CN012-0008, KAR-012
Acronym
ARISE
Status last verified
Apr 2026
First submitted
23 Nov 2021
Last updated
5 May 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xanomeline and Trospium Chloride Capsules in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 166 sites in 8 countries.

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 16 inclusion and 39 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Bulgaria, India, Serbia, Romania and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 May 2026). 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 6 (time frame: Baseline to Week 6). 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 NCT05145413.

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 5 May 2026.

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