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Pimavanserin for Schizophrenia

Phase 3
Recruiting
Research Sponsored by ACADIA Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Main background antipsychotic must be one of the specified antipsychotics
Female subjects must not be pregnant or breastfeeding and must use contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial looks at the safety and tolerability of a drug called pimavanserin when used to treat schizophrenia.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects include risks associated with heart rhythm (long QT syndrome), sudden death, or torsade de pointes. Other possible side effects might relate to psychiatric stability or exacerbation of existing medical conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My main antipsychotic medication is one of the specified drugs.
Select...
I am not pregnant or breastfeeding and will use birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability])

Side effects data

From 2021 Phase 4 trial • 6 Patients • NCT04188392
33%
sleepiness
17%
diarrhea
17%
weight gain
17%
arthralgia
17%
dry mouth
17%
headache
17%
skin irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Treatment

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimavanserin
FDA approved

Find a Location

Who is running the clinical trial?

ACADIA Pharmaceuticals Inc.Lead Sponsor
46 Previous Clinical Trials
10,440 Total Patients Enrolled
7 Trials studying Schizophrenia
1,945 Patients Enrolled for Schizophrenia

Media Library

Pimavanserin Clinical Trial Eligibility Overview. Trial Name: NCT03121586 — Phase 3
Schizophrenia Research Study Groups: Drug - Pimavanserin
Schizophrenia Clinical Trial 2023: Pimavanserin Highlights & Side Effects. Trial Name: NCT03121586 — Phase 3
Pimavanserin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03121586 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are needed for this clinical trial?

"That is correct, the information on clinicaltrials.gov verifies that this study is currently looking for participants. The posting date was January 1st 2017 and the most recent update was on August 30th 2022. They are recruiting 500 patients from 2 different locations."

Answered by AI

Is this a new or unique study?

"Pimavanserin has been the focus of 6 clinical trials since 2017, with the first being sponsored by ACADIA Pharmaceuticals Inc. After this initial trial involving 500 patients, Pimavanserin received Phase 3 drug approval in 2017. Currently, there are 101 cities and 20 countries with active studies on Pimavanserin's effects."

Answered by AI

Can Pimavanserin have negative consequences for human health?

"Pimavanserin has received a score of 3 for safety from our team at Power. This is because it is a phase 3 trial, which suggests that not only does this drug have some evidence supporting efficacy, but also multiple rounds of data affirming its safety."

Answered by AI

Can new patients still enroll in this research project?

"The listed information on clinicaltrials.gov says that this trial is looking for participants right now. The first posting was on 1/1/2017, with the most recent update taking place on 8/30/2022. They need 500 people total from 2 different locations."

Answered by AI

What other scientific investigations have included Pimavanserin?

"Pimavanserin was first studied in 2017 at SPHI. Since the completion of the original clinical trial, there have been 18 more. Presently, there are 6 live trials taking place across Jamaica and New york."

Answered by AI
~61 spots leftby Mar 2025