SchizophreniaPhase 3NCT00150176

To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)

A Phase 3 study testing Asenapine - Open Label and Asenapine - Double Blind 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.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Schizophrenia
What is being tested?: Asenapine - Open Label and Asenapine - Double Blind
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 831 participants
Where: No sites listed yet
Study dates: Apr 2005to Jul 2008
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

Have a primary diagnosis of schizophrenia
History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening
History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening
Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms

Who cannot join

Have an uncontrolled, unstable clinically significant medical condition
History of suicide attempt or significant violence to others in the past 2 years
A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
Current substance abuse/dependence
Concurrent psychiatric disorder other than schizophrenia.

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia

Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.

Conditions: Schizophrenia
Being tested: Asenapine - Open Label, Placebo - Double Blind, Asenapine - Double Blind
Medical subject headings: Schizophrenia

What participants receive

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

Asenapine - Open LabelDrug
Also called Saphris, Org 5222, SCH 900274
Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).
Placebo - Double BlindDrug
Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.
Asenapine - Double BlindDrug
Also called Org 5222, SCH 900274, Saphris
Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.

Study groups in NCT00150176
Study group	Role	What they receive
asenapine	Experimental	Not described Receives: Drug: Asenapine - Open Label; Drug: Asenapine - Double Blind
placebo	Placebo comparator	Not described Receives: Drug: Asenapine - Open Label; Drug: Placebo - Double Blind

What is being measured

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

Time to Relapse or an Impending Relapse
A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.
Measured: time of first relapse up to Day 182 (double blind phase)

Secondary outcomes (1)

Time to Early Discontinuation for Any Reason
The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).
Measured: time of discontinuation up to Day 182 (double blind phase)

Timeline

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

Apr 2005Jul 2008

First posted8 Sep 2005 (estimated)
Study startApr 2005
Primary completionJun 2008
Study completionJul 2008

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 831 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00150176
Sponsor's protocol ID: P05770
Other IDs: A7501012
Status last verified: Feb 2022
First submitted: 2 Sep 2005
Last updated: 8 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kane JM, Mackle M, Snow-Adami L, Zhao J, Szegedi A, Panagides J. A randomized placebo-controlled trial of asenapine for the prevention of relapse of schizophrenia after long-term treatment. J Clin Psychiatry. 2011 Mar;72(3):349-55. doi: 10.4088/JCP.10m06306. Epub 2011 Feb 22.
PubMed 21367356

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

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia
ClinicalTrials.gov ID: NCT00150176
Acronym / sponsor ID: P05770
Conditions: Schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 831 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Jun 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 8 Sep 2005 (estimated)
Results: Posted 28 May 2010

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
asenapine	Experimental	Drug: Asenapine - Open Label, Drug: Asenapine - Double Blind
placebo	Placebo comparator	Drug: Asenapine - Open Label, Drug: Placebo - Double Blind

Who may qualify

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

Key inclusion criteria (4 listed)

Have a primary diagnosis of schizophrenia
History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening
History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening
Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms

Key exclusion criteria (5 listed)

Have an uncontrolled, unstable clinically significant medical condition
History of suicide attempt or significant violence to others in the past 2 years
A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
Current substance abuse/dependence
Concurrent psychiatric disorder other than schizophrenia.

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
Asenapine - Open LabelAlso: Saphris, Org 5222, SCH 900274Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).	Drug	asenapine, placebo
Placebo - Double BlindDouble Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.	Drug	placebo
Asenapine - Double BlindAlso: Org 5222, SCH 900274, SaphrisDouble Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.	Drug	asenapine

Primary outcome

Time to Relapse or an Impending Relapse
Time frame: time of first relapse up to Day 182 (double blind phase)
A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.

1 secondary outcome

Time to Early Discontinuation for Any Reason
Time frame: time of discontinuation up to Day 182 (double blind phase)

Results and safety

Results posted to the registry on 28 May 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	194	135
Placebo	192	72

Primary outcome: Time to Relapse or an Impending Relapse

Time frame: time of first relapse up to Day 182 (double blind phase). Number. Unit: relapses

Measure	Asenapine n = 190	Placebo n = 190
Days 1 - 7 (N asenapine = 190; N placebo = 190)	0	3
Days 8 - 14 (N asenapine = 188; N placebo = 186)	1	14
Days 15 - 21 (N asenapine = 183; N placebo = 170)	2	9
Days 22 - 28 (N asenapine = 180; N placebo = 160)	2	8
Days 29 - 35 (N asenapine = 175; N placebo = 149)	0	7
Days 36 - 42 (N asenapine = 175; N placebo = 140)	1	8
Days 43 - 49 (N asenapine = 173; N placebo = 130)	5	2
Days 50 - 56 (N asenapine = 166; N placebo = 127)	1	4

Population analysed: ITT population, excluding subjects not treated and w/ past enrollment in an asenapine trial. As trial progressed \& subjects discont'd for various reasons, subjects at risk for relapse decreased from 190 each arm (Day 1) to 70 at risk in placebo arm and 135 subjects in asenapine arm (Day 182). Those relapsing \>3 days after last dose also excluded.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Asenapine	6 of 194 (3.1%)	121 of 194 (62.4%)	Not reported
Placebo	22 of 192 (11.5%)	127 of 192 (66.1%)	Not reported
Asenapine During Open-Label Phase and Not Randomized	39 of 314 (12.4%)	170 of 314 (54.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21367356Kane JM, Mackle M, Snow-Adami L, Zhao J, Szegedi A, Panagides J. A randomized placebo-controlled trial of asenapine for the prevention of relapse of schizophrenia after long-term treatment. J Clin Psychiatry. 2011 Mar;72(3):349-55. doi: 10.4088/JCP.10m06306. Epub 2011 Feb 22.

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Not yet recruitingObservational study
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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 - Open Label and Asenapine - Double Blind 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 4 inclusion and 5 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 8 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. Some participants in this study may receive a placebo. 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 28 May 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?

Time to Relapse or an Impending Relapse (time frame: time of first relapse up to Day 182 (double blind phase)). 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 NCT00150176, 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 8 Feb 2022.