6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00265343
• Collaborator: (none)
• Enrollment: 306
• Arms: 2
• Duration (Months): 25

Study Details

Study Description

Brief Summary

This is an extension study to further test

the efficacy and safety of asenapine compared with a

marketed agent (olanzapine) in the treatment of patients with

persistent negative symptoms of schizophrenia.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: asenapine; Drug: olanzapine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 306 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed the Protocol 25543 (NCT 00212836; P05817)
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 asenapine	Drug: asenapine; 5-10 mg sublingually twice daily for 26 weeks
Active Comparator: 2 olanzapine	Drug: olanzapine; 5-20 mg by mouth once daily for 26 weeks

Outcome Measures

Primary Outcome Measures

1. Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale [Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)]

   Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst].

Secondary Outcome Measures

1. Change in Quality of Life Measured by Quality of Life Scale (QLS) [Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)]

   Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Continue to meet all demographic and procedural

inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into

this extension trial.

• Have demonstrated an acceptable

degree of compliance and completed the 25543

trial, and would benefit from continued treatment

according to the investigator.

Exclusion Criteria:

• Have an uncontrolled, unstable clinically significant

medical condition.

• Have been judged to be medically

noncompliant in the management of their disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00265343
• Other Study ID Numbers: P05777; 25544; Aphrodite
• First Posted: Dec 14, 2005
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Schizophrenia; Olanzapine; Asenapine

Study Results

Participant Flow

Arm/Group Title	Asenapine	Olanzapine
Arm/Group Description	5-10 mg twice daily (bid) sublingual (SL)	5-20 mg daily (QD) orally (PO)
Period Title: Overall Study
STARTED	134	172
COMPLETED	113	153
NOT COMPLETED	21	19

Baseline Characteristics

Arm/Group Title	Asenapine	Olanzapine	Total
Arm/Group Description	5-10 mg twice daily (bid) sublingual (SL)	5-20 mg daily (QD) orally (PO)	Total of all reporting groups
Overall Participants	134	172	306
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.9 (12.2)	40.7 (11.7)	40.4 (11.9)
Sex: Female, Male (Count of Participants)
Female	43 32.1%	53 30.8%	96 31.4%
Male	91 67.9%	119 69.2%	210 68.6%

Outcome Measures

1. Primary Outcome

Title	Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale
Description	Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst].
Time Frame	Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Asenapine	Olanzapine
Arm/Group Description	5-10 mg twice daily (bid) sublingual (SL)	5-20 mg daily (QD) orally (PO)
Measure Participants	122	157
Least Squares Mean (Standard Error) [Units on a Scale]	-16.9 (0.98)	-15.4 (0.85)

2. Secondary Outcome

Title	Change in Quality of Life Measured by Quality of Life Scale (QLS)
Description	Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].
Time Frame	Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Asenapine	Olanzapine
Arm/Group Description	5-10 mg twice daily (bid) sublingual (SL)	5-20 mg daily (QD) orally (PO)
Measure Participants	122	157
Least Squares Mean (Standard Error) [Units on a Scale]	18.7 (1.64)	16.4 (1.4)

Adverse Events

Arm/Group Title	Asenapine		Olanzapine
Arm/Group Description
All Cause Mortality
	Asenapine		Olanzapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Asenapine		Olanzapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/134 (6.7%)		6/172 (3.5%)
Cardiac disorders
Myocardial infarction	0/134 (0%)	0	1/172 (0.6%)	1
Gastrointestinal disorders
Nausea	0/134 (0%)	0	1/172 (0.6%)	1
Vomiting	0/134 (0%)	0	1/172 (0.6%)	1
Infections and infestations
Salmonellosis	1/134 (0.7%)	1	0/172 (0%)	0
Injury, poisoning and procedural complications
Fall	1/134 (0.7%)	1	0/172 (0%)	0
Fibula fracture	1/134 (0.7%)	1	0/172 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/134 (0%)	0	1/172 (0.6%)	1
Nervous system disorders
Dementia	1/134 (0.7%)	1	0/172 (0%)	0
Psychiatric disorders
Anxiety	1/134 (0.7%)	1	0/172 (0%)	0
Nervousness	1/134 (0.7%)	3	0/172 (0%)	0
Psychotic disorder	1/134 (0.7%)	1	0/172 (0%)	0
Schizophrenia	4/134 (3%)	4	3/172 (1.7%)	3
Stress	1/134 (0.7%)	3	0/172 (0%)	0
Surgical and medical procedures
Surgery	0/134 (0%)	0	1/172 (0.6%)	1
Other (Not Including Serious) Adverse Events
	Asenapine		Olanzapine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/134 (14.2%)		21/172 (12.2%)
Infections and infestations
Influenza	7/134 (5.2%)	7	3/172 (1.7%)	3
Investigations
Weight increased	0/134 (0%)	0	11/172 (6.4%)	11
Nervous system disorders
Headache	7/134 (5.2%)	8	7/172 (4.1%)	8
Psychiatric disorders
Schizophrenia	7/134 (5.2%)	8	1/172 (0.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publication/presentation of data may not be made without prior review and comment by the Sponsor; all reasonable comments of Sponsor will be incorporated as far as the scientific data content is not impaired. A complete copy shall be provided to the Sponsor at least 60 days prior to date of submission. Participation in the Study involves a commitment to publish data from the study in a cooperative publication prior to publication/presentation or on an individual basis.