A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents (SWITCHCore)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sunovion

ClinicalTrials.gov Identifier:

NCT01143077

First received: June 10, 2010

Last updated: April 9, 2013

Last verified: April 2013

History of Changes

Results First Received: May 15, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel 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 June 24, 2010-LPV May 19, 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
Lurasidone Open-Label Arm 40/40	Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
Lurasidone Open-Label Arm 40/80	Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
Lurasidone Open-Label Arm 80/80	Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks

Participant Flow: Overall Study

	Lurasidone Open-Label Arm 40/40	Lurasidone Open-Label Arm 40/80	Lurasidone Open-Label Arm 80/80
STARTED	74	88	82
COMPLETED	58	73	67
NOT COMPLETED	16	15	15
Lack of Efficacy	0	2	1
Adverse Event	5	6	5
Lost to Follow-up	2	3	4
Protocol Violation	2	0	0
Withdrawal by Subject	4	3	3
Non-compliance with study drug	0	1	1
Administrative	1	0	0
Principal Investigator Decision	2	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Lurasidone Open-Label Arm 40/40	Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
Lurasidone Open-Label Arm 40/80	Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
Lurasidone Open-Label Arm 80/80	Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
Total	Total of all reporting groups

Baseline Measures

Lurasidone Open-Label Arm 40/40

Lurasidone Open-Label Arm 40/80

Lurasidone Open-Label Arm 80/80

Total

Overall Participants Analyzed
[Units: Participants]

240

Age ^[1]
[Units: Participants]

<=18 years

Between 18 and 65 years

237

>=65 years

^[1]	244 patients were randomized, 240 received study medication.

Age ^[1]
[Units: Years]
Mean (Standard Deviation)

43.2 (11.3)

44.0 (11.5)

44.4 (10.0)

43.9 (10.9)

^[1]	244 patients were randomized, 240 received study medication.

Gender ^[1]
[Units: Participants]

Female

Male

156

^[1]	244 patients were randomized, 240 received study medication.

Region of Enrollment ^[1]
[Units: Participants]

United States

240

^[1]	244 patients were randomized, 240 received study medication.

Outcome Measures

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1. Primary:

Time to Relapse of Psychotic Symptoms During 6 Weeks [ Time Frame: 6 Weeks ]

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2. Secondary:

Tolerability and Safety [ Time Frame: 6 Weeks ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Lurasidone Open-Label Arm 40/40	Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
Lurasidone Open-Label Arm 40/80	Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
Lurasidone Open-Label Arm 80/80	Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks

Serious Adverse Events

	Lurasidone Open-Label Arm 40/40	Lurasidone Open-Label Arm 40/80	Lurasidone Open-Label Arm 80/80
Total, Serious Adverse Events
# participants affected / at risk	3/72 (4.17%)	2/87 (2.30%)	0/81 (0.00%)
Musculoskeletal and connective tissue disorders
Osteoarthritis ^†
# participants affected / at risk	1/72 (1.39%)	0/87 (0.00%)	0/81 (0.00%)
# events	1	0	0
Psychiatric disorders
Alcoholism ^†
# participants affected / at risk	0/72 (0.00%)	1/87 (1.15%)	0/81 (0.00%)
# events	0	1	0
Schizoaffective disorder ^†
# participants affected / at risk	2/72 (2.78%)	0/87 (0.00%)	0/81 (0.00%)
# events	2	0	0
Schizophrenia ^†
# participants affected / at risk	1/72 (1.39%)	0/87 (0.00%)	0/81 (0.00%)
# events	1	0	0
Sexually inappropriate behavior ^†
# participants affected / at risk	0/72 (0.00%)	1/87 (1.15%)	0/81 (0.00%)
# events	0	1	0

†	Events were collected by systematic assessment

Other Adverse Events

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Limitations and Caveats

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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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