Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00145496

First received: September 1, 2005

Last updated: March 13, 2013

Last verified: March 2013

History of Changes

Results First Received: March 5, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Schizophrenia
Interventions:	Drug: Asenapine Drug: Olanzapine

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
Asenapine	5-10 mg sublingually twice daily for up to 26 weeks
Olanzapine	5-20 mg by mouth once daily for up to 26 weeks

Participant Flow: Overall Study

	Asenapine	Olanzapine
STARTED	244 ^[1]	224 ^[1]
COMPLETED	121	143
NOT COMPLETED	123	81
Adverse Event	42	30
Lack of Efficacy	12	7
Withdrawal by Subject	32	26
Lost to Follow-up	12	5
Other	25	13

[1]	Subjects who received randomized treatment assignment and at least one dose of study medication.

Baseline Characteristics

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Reporting Groups

	Description
Asenapine	5-10 mg sublingually twice daily for up to 26 weeks
Olanzapine	5-20 mg by mouth once daily for up to 26 weeks
Total	Total of all reporting groups

Baseline Measures

	Asenapine	Olanzapine	Total
Number of Participants [units: participants]	244	224	468
Age, Customized [units: participants]
<18 years	0	0	0
18 to 64 years	239	217	456
>=65 years	5	7	12
Age [units: years] Mean ± Standard Deviation	43.1 ± 11.43	42.8 ± 11.27	42.9 ± 11.34
Gender [units: participants]
Female	68	54	122
Male	176	170	346
Body Weight [units: kg] Mean ± Standard Deviation	84.0 ± 19.01	85.7 ± 18.71	84.8 ± 18.86

Outcome Measures

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1. Primary:

Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score [ Time Frame: Day 182 ]

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2. Secondary:

Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score [ Time Frame: Day 182 ]

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3. Secondary:

Change From Baseline in Body Weight [ Time Frame: Day 182 ]

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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: Except for compelling legal reasons, neither the sponsor nor the investigator will communicate to third parties any result of the clinical trial before the clinical trial report has been released by the sponsor.

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: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00145496 History of Changes
Other Study ID Numbers:	A7501013, Aphrodite;, P05771
Study First Received:	September 1, 2005
Results First Received:	March 5, 2010
Last Updated:	March 13, 2013
Health Authority:	United States: Food and Drug Administration

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