Clinical trials

8

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Participants needed: 410
Trial details
Phase: Phase 3Age: 55-90Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Aug 17, 2026Locations: 129
Eligibility criteria

Is aged 55 to 90 years, inclusive, at Screening [+11]

Psychotic symptoms that are primarily attributable to a condition other than the... [+24]

Status: Recruiting

A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

Participants needed: 400
Trial details
Phase: Phase 3Age: 5-17Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Aug 13, 2026Locations: 95
Eligibility criteria

Participants must not have a significant risk of committing violent acts, seriou... [+3]

Status: Recruiting

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Participants needed: 406
Trial details
Phase: Phase 3Age: 55-90Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jul 30, 2026Locations: 292
Eligibility criteria

Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Vis... [+3]

Status: Recruiting

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

Participants needed: 500
Trial details
Phase: Phase 3Age: 55-90Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jul 30, 2026Locations: 154
Eligibility criteria

Is a male or female aged 55 to 90 years, inclusive, at Screening. [+10]

Psychotic symptoms that are primarily attributable to a condition other than the... [+9]

Status: Recruiting

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

Participants needed: 1,000
Trial details
Phase: Phase 3Age: 55-90Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jul 6, 2026Locations: 429
Eligibility criteria

Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-00... [+3]

Significant or severe medical conditions that, in the opinion of the Investigato... [+3]

Status: Not yet recruiting

Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Participants needed: 472
Trial details
Phase: Phase 3Age: 18-65Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jul 7, 2026Locations: 61
Eligibility criteria

Participant must have a primary diagnosis of schizophrenia for at least 1 year e... [+8]

Participant must not have any primary DSM-5 disorder other than schizophrenia wi... [+6]

Status: Not yet recruiting

Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers

This study looks at how to reduce nausea and vomiting in people taking KarXT which is used to treat mental health conditions like schizophrenia. KarXT can cause stomach-related side effects, especially in the first couple of weeks. In this study, healthy volunteers will take KarXT along with anti-nausea medication, either regularly (to prevent symptoms) or as needed. The goal is to see how well these strategies help reduce nausea and vomiting and how safe the combination is. The results will help doctors better manage side effects and make treatment more comfortable for patients starting KarXT.

Participants needed: 225
Trial details
Phase: Phase 4Age: 18-65Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Jul 2, 2026
Eligibility criteria

Participants must be healthy male and female participants as determined by no cl... [+3]

Participants must not have history or presence of clinically significant cardiov... [+4]

Status: Recruiting

A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants

The purpose of this study is to evaluate the pharmacokinetics (PK) of xanomeline following administration of KarXT in CYP2D6 normal/extensive, intermediate, poor, and ultrarapid metabolizers.

Participants needed: 56
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb companyUpdated: Feb 19, 2026Locations: 3
Eligibility criteria

Participant must be healthy male and female (INOCBP) participants as determined... [+2]

Participants must not have evidence of organ dysfunction or any clinically signi... [+1]