6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)

A Phase 3 study testing asenapine and olanzapine in people with Schizophrenia, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is an extension study of A7501013 (P05771/NCT00145496) 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Schizophrenia
What is being tested?: asenapine and olanzapine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: No sites listed yet
Study dates: Jul 2005to May 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Continue to meet all demographic and procedural
this extension trial.
Have demonstrated an acceptable degree of compliance
and completed the A7501013 trial, and would benefit
from continued treatment according to the investigator.

Who cannot join

Have an uncontrolled, unstable clinically significant
medical condition.
Have been judged to be medically noncompliant in the
management of their disease.

About this study

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 Protocol A7501013

This is an extension study of A7501013 (P05771/NCT00145496) 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.

Conditions: Schizophrenia
Being tested: asenapine, olanzapine
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

asenapineDrug
5-10 mg sublingually twice daily for 26 weeks
olanzapineDrug
Also called Zyprexa
5-20 mg by mouth once daily for 26 weeks

Study groups in NCT00174265
Study group	Role	What they receive
asenapine	Experimental	Not described Receives: Drug: asenapine
olanzapine	Active comparator	Not described Receives: Drug: olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.
Measured: Baseline of A7501013 to Day 365

Secondary outcomes (1)

Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score
The QLS 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 (worst) to 126 (best), with greater values indicating better quality of life.
Measured: Baseline of A7501013 to Day 365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005May 2009

First posted15 Sep 2005 (estimated)
Study startJul 2005
Primary completionApr 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00174265
Sponsor's protocol ID: P05772
Other IDs: Aphrodite, A7501014
Status last verified: Feb 2022
First submitted: 9 Sep 2005
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.
PubMed 22198451

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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 Protocol A7501013
ClinicalTrials.gov ID: NCT00174265
Acronym / sponsor ID: P05772
Conditions: Schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Apr 2009 (actual)
Study completion: May 2009 (actual)
First posted: 15 Sep 2005 (estimated)
Results: Posted 5 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an extension study of A7501013 (P05771/NCT00145496) 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
asenapine	Experimental	Drug: asenapine
olanzapine	Active comparator	Drug: olanzapine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Continue to meet all demographic and procedural
this extension trial.
Have demonstrated an acceptable degree of compliance
and completed the A7501013 trial, and would benefit
from continued treatment according to the investigator.

Key exclusion criteria (4 listed)

Have an uncontrolled, unstable clinically significant
medical condition.
Have been judged to be medically noncompliant in the
management of their disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
asenapine5-10 mg sublingually twice daily for 26 weeks	Drug	asenapine
olanzapineAlso: Zyprexa5-20 mg by mouth once daily for 26 weeks	Drug	olanzapine

Primary outcome

Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
Time frame: Baseline of A7501013 to Day 365
The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.

1 secondary outcome

Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score
Time frame: Baseline of A7501013 to Day 365

Results and safety

Results posted to the registry on 5 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Asenapine	86	57
Olanzapine	110	89

Primary outcome: Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score

Time frame: Baseline of A7501013 to Day 365. Least squares mean (Standard Error). Unit: Units on a Scale

Measure	Asenapine n = 83	Olanzapine n = 110
Baseline	61.5 (1.37)	60.3 (1.20)
Change from Baseline at Day 365	-15.8 (1.48)	-11.0 (1.27)

Asenapine vs Olanzapine: p = 0.0148, Mixed Model for Repeated Measurements

Population analysed: Intent-to-treat (ITT) population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the Mixed Model for Repeated Measurements (MMRM) model.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Asenapine	4 of 85 (4.7%)	14 of 85 (16.5%)	Not reported
Olanzapine	4 of 110 (3.6%)	31 of 110 (28.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22198451Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing asenapine and olanzapine in people with Schizophrenia, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score (time frame: Baseline of A7501013 to Day 365). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00174265, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.