KarXT for Schizophrenia

Phase 3

Recruiting

Research Sponsored by Karuna Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing and able to discontinue all antipsychotic medications prior to baseline visit

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 (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.2

Must not have

Any primary DSM-5 disorder other than schizophrenia within 12 months before screening

History of treatment resistance to schizophrenia medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 11 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to test whether gradually increasing the dose of KarXT and taking it with food is safe and effective for adults with schizophrenia."

Who is the study for?

This trial is for adults with schizophrenia. Specific eligibility criteria are not provided, but typically participants must meet diagnostic criteria for schizophrenia and be stable enough to participate in a clinical study.

What is being tested?

The trial is testing KarXT, focusing on how safe and effective it is when the dose is increased slowly. It also looks at whether taking the drug with food affects its performance.

What are the potential side effects?

While specific side effects of KarXT are not listed here, common side effects for medications treating schizophrenia may include drowsiness, weight gain, dry mouth, restlessness, and sometimes more serious effects like movement disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to stop taking all antipsychotic medications before my first visit.

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I have been diagnosed with schizophrenia by a psychiatrist.

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My mental health condition is not severely impacting my daily life.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been diagnosed with a mental health condition other than schizophrenia in the past year.

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My schizophrenia medications have not worked in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 11 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 11 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 11 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in clinical laboratory assessment (Clinical chemistry)

Change from baseline in clinical laboratory assessment (Hematology)

Change from baseline in orthostatic vital signs (supine and standing after 2 minutes) at Day 7 and Day 14: blood pressure (systolic and diastolic) and heart rate

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