Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

This study has been completed.

Study NCT00615433 Information provided by Sunovion

First Received on February 1, 2008. Last Updated on September 6, 2011 History of Changes

Results First Received: November 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Schizophrenia
Interventions:	Drug: Lurasidone Drug: Olanzapine Drug: Placebo comparator Drug: Lurasidone 40 mg tablets

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
40mg	Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
120mg	3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
15mg Olz	3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
Placebo	Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).

Participant Flow: Overall Study

	40mg	120mg	15mg Olz	Placebo
STARTED	120	119	123	116
COMPLETED	77	66	84	71
NOT COMPLETED	43	53	39	45

Baseline Characteristics

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Reporting Groups

	Description
40mg	Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
120mg	3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
15mg Olz	3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
Placebo	Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).

Baseline Measures

	40mg	120mg	15mg Olz	Placebo	Total
Number of Participants [units: participants]	119	118	122	116	475
Age [units: years] Mean ± Standard Deviation	37.7 ± 11.0	37.9 ± 11.2	38.3 ± 10.2	36.9 ± 11.3	37.7 ± 10.9
Gender [units: participants]
Female	26	25	27	26	104
Male	93	93	95	90	371
Region of Enrollment [units: participants]
United States	70	72	74	68	284
Philippines	7	6	8	5	26
Lithuania	7	7	7	8	29
Colombia	12	12	12	12	48
India	23	21	21	23	88

Outcome Measures

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1. Primary:

Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period. [ Time Frame: Baseline and 6 weeks ]

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2. Secondary:

CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment. [ Time Frame: 6 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: For multi-center studies, it is mandatory that the first publication is based on all data obtained from all analyses as stipulated in the protocol. Investigators participating in multicenter studies must agree not to present data gathered individually or by subgroup of centers before the full, initial publication, unless this has been agreed to by all other investigators and also by Sunovion.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Josephine Cucchiaro, Executive Director
Organization: Sunovion Pharmacetuicals Inc.
phone: 201-592-2050
e-mail: josephine.cucchiaro@sunovion.com

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00615433 History of Changes
Other Study ID Numbers:	D1050231
Study First Received:	February 1, 2008
Results First Received:	November 8, 2010
Last Updated:	September 6, 2011
Health Authority:	United States: Food and Drug Administration