A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder (Switch Ext)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sunovion

ClinicalTrials.gov Identifier:

NCT01143090

First received: June 10, 2010

Last updated: January 3, 2013

Last verified: January 2013

History of Changes

Results First Received: November 15, 2012

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Schizophrenia Schizoaffective Disorder
Intervention:	Drug: Lurasidone HCl

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
FPI August 10, 2010-LPV November 28, 2011, locations were private health clinics, university hospitals, private research facilities.

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
Open Label	Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study.

Participant Flow: Overall Study

	Open Label
STARTED	149
COMPLETED	98
NOT COMPLETED	51
Lack of Efficacy	2
Adverse Event	17
Lost to Follow-up	9
Protocol Violation	2
Withdrawal by Subject	18
Non-compliance with study drug	1
Failure to meet eligibility criteria	1
Administrative	1

Baseline Characteristics

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Reporting Groups

	Description
Open Label	Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.

Baseline Measures

	Open Label
Number of Participants [units: participants]	148
Age [units: participants]
<=18 years	2
Between 18 and 65 years	146
>=65 years	0
Age [units: years] Mean ± Standard Deviation	42.8 ± 11.1
Gender [units: participants]
Female	55
Male	93
Region of Enrollment ^[1] [units: participants]
United States	148

[1]	One enrolled subject did not receive any study medication and was excluded from this summary.

Outcome Measures

1. Primary:

Adverse Events [ Time Frame: 6 months ]

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2. Secondary:

Efficacy [ Time Frame: 6 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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: In addition to the <60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; provided, if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.

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: Medical Director, CNS
Organization: Sunovion Pharmaceuticals Inc
phone: 1-866-503-6351

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT01143090 History of Changes
Other Study ID Numbers:	D1050290
Study First Received:	June 10, 2010
Results First Received:	November 15, 2012
Last Updated:	January 3, 2013
Health Authority:	United States: Food and Drug Administration

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