Pimavanserin for Schizophrenia

Recruiting in Palo Alto (17 mi)

+213 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ACADIA Pharmaceuticals Inc.

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

Research Team

Eligibility Criteria

This trial is for individuals with schizophrenia who are finishing a previous pimavanserin study and may benefit from continued treatment. They must understand the consent process, have a reliable caregiver, not be pregnant or breastfeeding, agree to use two contraception methods if female, and abstain from marijuana and other prohibited substances.

Inclusion Criteria

Completing the specified visits in the respective studies while continuing the assigned dose of blinded study drug

I understand the study and have signed the consent form.

Has a caregiver or some other identified responsible person considered reliable by the Investigator

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Exclusion Criteria

Positive urine drug screen for prohibited substances

Patient is judged inappropriate for the study

Taking prohibited medications or substances

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Treatment Details

Interventions

Pimavanserin (Serotonin inverse agonist/antagonist)

Trial OverviewThe trial is testing the long-term safety of pimavanserin as an additional treatment over 52 weeks in patients with schizophrenia. It aims to see how well people tolerate this drug when taken alongside their usual antipsychotic medication.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Drug - PimavanserinExperimental Treatment1 Intervention

Pimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth