SchizophreniaPhase 3NCT00156065

Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)

A Phase 3 study testing Haloperidol and Asenapine 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?: Haloperidol and Asenapine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 187 participants
Where: No sites listed yet
Study dates: Sep 2005to Oct 2007
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

Completed the short-term 041023 trial (NCT00156104)
Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial
Sign a written informed consent for the 041513 trial.
Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator

Who cannot join

CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic)
Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation
Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial
Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.

About this study

Official title: A Multicenter, Randomized, Double-Blind, Flexible-Dose, Long-Term Extension Trial of the Safety and Maintenance of Effect of Asenapine Using Haloperidol Positive Control in Subjects Who Complete Protocol 041023 [NCT00156104]

Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. 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.

The clinical development of asenapine, as described in the 2007 IDB appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics. Its fast dissolving formulation may further add to treatment compliance. While various titration schedules have been used in previous studies, dose increases at 5 mg BID (twice daily) up to 10 mg BID have been well tolerated. Therefore, further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual clinical practice in a long-term 52-week extension trial.

Conditions: Schizophrenia
Being tested: Haloperidol, Asenapine
Medical subject headings: Schizophrenia

What participants receive

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

HaloperidolDrug
2-8 mg BID
AsenapineDrug
5 or 10 mg BID
AsenapineDrug
5 or 10 mg BID

Study groups in NCT00156065
Study group	Role	What they receive
Haloperidol/Haloperidol	Active comparator	Haloperidol in original study (NCT00156104) and in current long-term extension. Receives: Drug: Haloperidol
Asenapine/Asenapine	Experimental	Asenapine in original study and asenapine in current long-term extension. Receives: Drug: Asenapine
Placebo/Asenapine	Experimental	Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041023 asenapine trial, were randomized (double-blind) into the long-term 041513 asenapine extension trial and received asenapine 5 mg BID for Week 1. After Week 1, subjects received asenapine (either 5 mg BID or 10 mg BID) for the remainder of the 52-week trial. Receives: Drug: Asenapine

What is being measured

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

Loss of Effect Over Time
Loss of effect in subjects who had >=30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score at the end of the original trial (NCT00156104) preceding the long-term extension.
PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity.
Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy.
Measured: Throughout the 52 weeks of the trial.
Median Survival Time of Effect
Kaplan-Meier estimate of median time to loss of effect in subjects who had >=30% decrease from baseline in PANSS score at the end of the original trial (NCT00156104) preceding the long-term extension.
PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity.
Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy.
Measured: 52 Weeks

Timeline

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

Sep 2005Oct 2007

First posted12 Sep 2005 (estimated)
Study startSep 2005
Primary completionSep 2007
Study completionOct 2007

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.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 187 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00156065
Sponsor's protocol ID: P05785
Other IDs: Hera;, 41513
Status last verified: Feb 2022
First submitted: 7 Sep 2005
Last updated: 8 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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
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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 Multicenter, Randomized, Double-Blind, Flexible-Dose, Long-Term Extension Trial of the Safety and Maintenance of Effect of Asenapine Using Haloperidol Positive Control in Subjects Who Complete Protocol 041023 [NCT00156104]
ClinicalTrials.gov ID: NCT00156065
Acronym / sponsor ID: P05785
Conditions: Schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 187 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Sep 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 7 Apr 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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Haloperidol/Haloperidol	Active comparator	Drug: HaloperidolHaloperidol in original study (NCT00156104) and in current long-term extension.
Asenapine/Asenapine	Experimental	Drug: AsenapineAsenapine in original study and asenapine in current long-term extension.
Placebo/Asenapine	Experimental	Drug: AsenapineDouble-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041023 asenapine trial, were randomized (double-blind) into the long-term 041513 asenapine extension trial and received asenapine 5 mg BID for Week 1. After Week 1, subjects received asenapine (either 5 mg BID or 10 mg BID) for the remainder of the 52-week trial.

Who may qualify

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

Key inclusion criteria (4 listed)

Completed the short-term 041023 trial (NCT00156104)
Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial
Sign a written informed consent for the 041513 trial.
Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator

Key exclusion criteria (4 listed)

CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic)
Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation
Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial
Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.

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
Haloperidol2-8 mg BID	Drug	Haloperidol/Haloperidol
Asenapine5 or 10 mg BID	Drug	Asenapine/Asenapine
Asenapine5 or 10 mg BID	Drug	Placebo/Asenapine

Primary outcome

Loss of Effect Over Time
Time frame: Throughout the 52 weeks of the trial.
Loss of effect in subjects who had >=30% decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score at the end of the original trial (NCT00156104) preceding the long-term extension. PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity. Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy.
Median Survival Time of Effect
Time frame: 52 Weeks
Kaplan-Meier estimate of median time to loss of effect in subjects who had >=30% decrease from baseline in PANSS score at the end of the original trial (NCT00156104) preceding the long-term extension. PANSS is a 30-item clinician-rated instrument for assessing symptoms of schizophrenia. Scores range from 30-210; higher scores indicate greater severity. Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy.

Results and safety

Results posted to the registry on 7 Apr 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
Placebo/Asenapine	51	20
Asenapine/Asenapine	93	30
Haloperidol/Haloperidol	43	16

Primary outcome: Loss of Effect Over Time

Time frame: Throughout the 52 weeks of the trial.. Number. Unit: Participants

Measure	Placebo/Asenapine n = 30	Asenapine/Asenapine n = 65	Haloperidol/Haloperidol n = 29
<=Week 1	7	15	6
>Week 1 to Week 2	3	4	4
>Week 2 to Week 4	1	14	3
>Week 4 to Week 8	3	3	1
>Week 8 to Week 12	2	1	1
>Week 12 to Week 16	3	1	4
>Week 16 to Week 20	0	1	1
>Week 20 to Week 24	0	3	0

Placebo/Asenapine: Kaplan-Meier Estimate of Loss of Effect: 0.8619 (95% CI 0.6912 to 0.9644)
Asenapine/Asenapine: Kaplan-Meier Estimate of Loss of Effect: 0.8834 (95% CI 0.7744 to 0.9550)
Haloperidol/Haloperidol: Kaplan-Meier Estimate of Loss of Effect: 0.9376 (95% CI 0.7631 to 0.9952)

Population analysed: These are participants who completed the original acute-phase trial (41023) with a decrease from baseline in Positive and Negative Syndrome Scale (PANSS) score \>= 30%, received at least one dose in the current long-term extension, and had at least one post-baseline PANSS assessment during the extension.

Primary outcome: Median Survival Time of Effect

Time frame: 52 Weeks. Median (95% Confidence Interval). Unit: Days

Measure	Placebo/Asenapine n = 30	Asenapine/Asenapine n = 65	Haloperidol/Haloperidol n = 29
Value	57 (15 to 111)	31 (28 to 140)	85 (15 to 118)

Adverse events

Time frame: Adverse events (AEs) were monitored continually through 52 weeks of treatment and 1 month of posttreatment follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo/Asenapine	12 of 50 (24%)	28 of 50 (56%)	Not reported
Asenapine/Asenapine	13 of 92 (14.1%)	54 of 92 (58.7%)	Not reported
Haloperidol/Haloperidol	6 of 43 (14%)	25 of 43 (58.1%)	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.

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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 Haloperidol and Asenapine 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 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 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. 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 7 Apr 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?

Loss of Effect Over Time (time frame: Throughout the 52 weeks of the trial.). The study lists 2 primary outcomes in all. 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 NCT00156065.

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.