Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Lurasidone HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00549718

2007-003819-31 (EudraCT Number)

D1050229

Details and patient eligibility

About

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Enrollment: 489 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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489 participants in 4 patient groups, including a placebo group

Lurasidone 40mg

Experimental group

Treatment:

Drug: Lurasidone HCl

Lurasidone 80mg

Experimental group

Treatment:

Drug: Lurasidone HCl

Lurasidone 120mg

Experimental group

Treatment:

Drug: Lurasidone HCl

Sugar Pill

Placebo Comparator group

Treatment:

Drug: Lurasidone HCl