Trial Outcomes & Findings for Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771) (NCT NCT00145496)

Last Updated: 2022-02-08

Results Overview

The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 to 96, with greater scores indicating greater severity of symptoms.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

468 participants

Primary outcome timeframe

Day 182

Results posted on

2022-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	244	224
Overall Study COMPLETED	121	143
Overall Study NOT COMPLETED	123	81

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	42	30
Overall Study Lack of Efficacy	12	7
Overall Study Withdrawal by Subject	32	26
Overall Study Lost to Follow-up	12	5
Overall Study Other	25	13

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asenapine n=244 Participants 5-10 mg sublingually twice daily for up to 26 weeks	Olanzapine n=224 Participants 5-20 mg by mouth once daily for up to 26 weeks	Total n=468 Participants Total of all reporting groups
Age, Continuous	43.1 years STANDARD_DEVIATION 11.43 • n=5 Participants	42.8 years STANDARD_DEVIATION 11.27 • n=7 Participants	42.9 years STANDARD_DEVIATION 11.34 • n=5 Participants
Age, Customized <18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized 18 to 64 years	239 participants n=5 Participants	217 participants n=7 Participants	456 participants n=5 Participants
Age, Customized >=65 years	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	54 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	176 Participants n=5 Participants	170 Participants n=7 Participants	346 Participants n=5 Participants
Body Weight	84.0 kg STANDARD_DEVIATION 19.01 • n=5 Participants	85.7 kg STANDARD_DEVIATION 18.71 • n=7 Participants	84.8 kg STANDARD_DEVIATION 18.86 • n=5 Participants

PRIMARY outcome

Timeframe: Day 182

Population: Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.

Outcome measures

Outcome measures
Measure	Asenapine n=234 Participants 5-10 mg sublingually twice daily for up to 26 weeks	Olanzapine n=218 Participants 5-20 mg by mouth once daily for up to 26 weeks
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score Baseline	60.4 Units on a Scale Standard Error 0.80	61.3 Units on a Scale Standard Error 0.80
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score Change From Baseline at Day 182	-9.7 Units on a Scale Standard Error 0.95	-9.2 Units on a Scale Standard Error 0.89

SECONDARY outcome

Timeframe: Day 182

Population: Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.

The Quality of Life Scale is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 to 126, with greater values indicating better quality of life.

Outcome measures

Outcome measures
Measure	Asenapine n=234 Participants 5-10 mg sublingually twice daily for up to 26 weeks	Olanzapine n=218 Participants 5-20 mg by mouth once daily for up to 26 weeks
Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score Baseline	46.3 Units on a Scale Standard Error 1.20	44.2 Units on a Scale Standard Error 1.20
Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score Change From Baseline at Day 182	11.1 Units on a Scale Standard Error 1.54	7.1 Units on a Scale Standard Error 1.41

SECONDARY outcome

Timeframe: Day 182

Population: Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value.

Outcome measures

Outcome measures
Measure	Asenapine n=234 Participants 5-10 mg sublingually twice daily for up to 26 weeks	Olanzapine n=218 Participants 5-20 mg by mouth once daily for up to 26 weeks
Change From Baseline in Body Weight Baseline	84.2 kg Standard Error 1.40	84.7 kg Standard Error 1.40
Change From Baseline in Body Weight Change From Baseline at Day 182	0.0 kg Standard Error 0.43	2.6 kg Standard Error 0.40

Adverse Events

Asenapine

Serious events: 30 serious events

Other events: 145 other events

Deaths: 0 deaths

Olanzapine

Serious events: 18 serious events

Other events: 140 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Asenapine n=244 participants at risk 5-10 mg sublingually twice daily for up to 26 weeks	Olanzapine n=224 participants at risk 5-20 mg by mouth once daily for up to 26 weeks
Gastrointestinal disorders DRY MOUTH	3.7% 9/244 • Number of events 9 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	8.0% 18/224 • Number of events 20 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.
Gastrointestinal disorders NAUSEA	8.2% 20/244 • Number of events 23 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	4.9% 11/224 • Number of events 12 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.
Investigations WEIGHT INCREASED	9.4% 23/244 • Number of events 23 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	21.4% 48/224 • Number of events 51 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.
Metabolism and nutrition disorders INCREASED APPETITE	3.3% 8/244 • Number of events 8 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	5.4% 12/224 • Number of events 16 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.
Nervous system disorders AKATHISIA	9.0% 22/244 • Number of events 29 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	5.8% 13/224 • Number of events 16 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.
Nervous system disorders DIZZINESS	7.4% 18/244 • Number of events 19 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	9.4% 21/224 • Number of events 26 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.
Nervous system disorders HEADACHE	13.5% 33/244 • Number of events 40 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	10.3% 23/224 • Number of events 26 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.
Nervous system disorders SEDATION	6.6% 16/244 • Number of events 17 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	7.6% 17/224 • Number of events 19 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.
Nervous system disorders SOMNOLENCE	14.8% 36/244 • Number of events 38 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	19.2% 43/224 • Number of events 62 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.
Psychiatric disorders ANXIETY	10.7% 26/244 • Number of events 37 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	7.1% 16/224 • Number of events 20 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.
Psychiatric disorders INSOMNIA	17.6% 43/244 • Number of events 55 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.	11.6% 26/224 • Number of events 34 • Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment. Information regarding AEs was obtained by questioning or examining the subject at each visit, and recording complaints and symptoms. Reports are for all SAEs and treatment-emergent nonserious AEs.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER