Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-05-31

Brief Summary

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The study evaluates the long term safety and efficacy of SM-13496 in patients with schizophrenia.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SM-13496

Group Type EXPERIMENTAL

SM-13496

Intervention Type DRUG

40 or 80 mg once daily orally

Interventions

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SM-13496

40 or 80 mg once daily orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are considered by the investigator eligible for the present study with no significant safety concerns
* Patients who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study

Exclusion Criteria

* Patients who are planning pregnancy for the expected duration of the study
* Patients who are otherwise considered ineligible for the study by the investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No