A phase III randomised, double-blind, active comparator-controlled clinical trial to study the safety and efficacy of lurasidone in subjects with schizophrenia (PEARL 3 extension study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN44297014

Enrollment

240

Registered

2009-05-26

Start date

2008-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia Mental and Behavioural Disorders Schizophrenia

Interventions

Subjects who meet entry criteria will continue treatment with either flexibly dosed lurasidone or quetiapine XR based on their treatment assignment in Study D1050233 in a double-blinded fashion. Subje

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Screening for the present study will take place after subjects' participation in Study D1050233 has been completed, and after providing informed consent. Principal inclusion criteria: 1. Males and females 18-75 years of age inclusive 2. Provide written informed consent 3. Completed all required assessments on the final study visit in Study D1050233 4. Suitable for treatment in an outpatient setting

Exclusion criteria

Exclusion criteria: 1. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia) 2. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property

Design outcomes

Primary

Measure	Time frame
1. Primary efficacy endpoint: 1.1. Time to relapse of psychotic symptoms in subjects to measure the long-term maintenance of antipsychotic efficacy of lurasidone compared with quetiapine XR. 2. Primary safety endpoints: The proportion of subjects with: 2.1. Adverse Events (AEs) 2.2. Discontinuations due to AEs 2.3. Serious Adverse Events (SAEs) AEs will be monitored throughout the study until Month 12.	—

Measure

Time frame

1. Primary efficacy endpoint: 1.1. Time to relapse of psychotic symptoms in subjects to measure the long-term maintenance of antipsychotic efficacy of lurasidone compared with quetiapine XR. 2. Primary safety endpoints: The proportion of subjects with: 2.1. Adverse Events (AEs) 2.2. Discontinuations due to AEs 2.3. Serious Adverse Events (SAEs) AEs will be monitored throughout the study until Month 12.

—

Secondary

Measure	Time frame
Efficacy endpoints of interest: Time to relapse of psychotic symptoms. Mean change from D1050233 baseline in the Positive and Negative Syndrome Scale (PANSS): positive score, negative score, and excitability score. PANSS will be carried out at Month 3, 6, 9, 12 in this extension study.	—

Countries

Colombia, Germany, India, Philippines, Romania, Russian Federation, Ukraine, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026