Safety and efficacy trial of two doses of lurasidone in acutely psychotic subjects with schizophrenia (PEARL 3)

Phase 3

Completed

• Conditions: Schizophrenia; Mental and Behavioural Disorders

• Registration Number: ISRCTN64695913
• Lead Sponsor: Dainippon Sumitomo Pharma America Inc. (USA)

Brief Summary

1. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/24035633 (added 10/04/2019) 2. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26117157 (added 10/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-26
• Study Completion: 2009-12-12
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Provide written informed consent and aged between 18 and 75 years of age (both males and females are eligible)
2. Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia
3. Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study
4. Able and agrees to remain off prior antipsychotic medication for the duration of study
5. Good physical health on the basis of medical history, physical examination, and laboratory screening
6. Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits

Exclusion Criteria

1. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property
2. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia)
3. Used investigational compound within 30 days
4. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Primary Efficacy Endpoint:<br> Mean change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at endpoint (Week 6).<br><br> Primary Safety Endpoints:<br> The proportion of subjects with the following at Week 6:<br> 1. Adverse Events (AEs)<br> 2. Discontinuations due to AEs<br> 3. Serious Adverse Events (SAEs)<br>

Secondary Outcome Measures

Name	Time	Method
<br> Key secondary efficacy endpoints:<br> Mean change from baseline in:<br> 1. Clinical Global Impressions Severity (CGI-S) score, assessed at baseline, Day 4, then every week until Week 6<br> 2. PANSS total score, assessed at baseline, Day 4, then every week until Week 6<br>