NCT00789698: PEARL 3 Ext

A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study)

Completed Phase 3 Results posted Last updated 19 May 2015

What this trial tests

Phase 3 trial testing Lurasidone HC1 in Chronic Schizophrenia in 240 participants. Completed in 1 July 2011.

Timeline

1 December 2008

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	240
Start date	1 December 2008
Primary completion	1 July 2011
Estimated completion	1 July 2011
Sites	65 locations across United States, Colombia, India, Romania, Russia, Ukraine

Drugs / interventions tested

• Lurasidone HC1 — full drug profile →
• Quetiapine XR

Conditions studied

• Chronic Schizophrenia — all drugs for Chronic Schizophrenia →

Sponsor

Sumitomo Pharma America, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Chronic Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Relapse of Psychotic Symptoms
  Time frame: 12 Months
  Time to relapse will be defined as the earliest occurrence of any of the following: * Worsening of \>= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale \>=3 * rehospitalization for worsening of psychosis * emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of

Sponsor's own description

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Weight change during long-term treatment with lurasidone: pooled analysis of studies in patients with schizophrenia.
   Meyer JM, Mao Y, Pikalov A, Cucchiaro J, et al · · 2015 · cited 24× · PMID 26196189 · DOI 10.1097/yic.0000000000000091
2. Schizophrenia relapse, patient considerations, and potential role of lurasidone.
   Citrome L. · · 2016 · cited 12× · PMID 27563237 · DOI 10.2147/ppa.s45401
3. Change in daytime sleepiness and cognitive function in a 6-month, double-blind study of lurasidone and quetiapine XR in patients with schizophrenia.
   Harvey PD, Siu CO, Loebel AD. · · 2016 · cited 6× · PMID 28740811 · DOI 10.1016/j.scog.2016.05.002
4. Lurasidone versus typical antipsychotics for schizophrenia.
   Storman D, Koperny M, Styczeñ K, Datka W, et al · · 2025 · cited 1× · PMID 39831535 · DOI 10.1002/14651858.cd012429.pub2