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Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia

NCT04531982 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2025-08-22

Study results available
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Summary

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of negative symptoms of schizophrenia

Conditions

Interventions

DRUG

Pimavanserin

Pimavanserin 34 mg, taken as two blinded 17 mg tablets once daily by mouth

DRUG

Placebo

Placebo, taken as two blinded tablets once daily by mouth

Sponsors & Collaborators

  • ACADIA Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2024-01-25
Completion
2024-02-19
FDA Drug
Yes

Countries

  • Argentina
  • Bulgaria
  • Croatia
  • Czechia
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Russia
  • Serbia
  • Spain
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04531982 on ClinicalTrials.gov