SchizophreniaPhase 3NCT00156091
Long-Term Efficacy and Safety of Asenapine Using Olanzapine as a Positive Control (41512)(COMPLETED)(P05784)
A Phase 3 study testing Olanzapine and Asenapine in people with Schizophrenia, run by Organon and Co.
Trial summary
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.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine and Asenapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 trial ( 041021 or 021022)
- 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 041512 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 score of greater or equal to 6 ( severely psychotic)
- Occurrence(s) of AE or other clinically significant findings that would prohibit their continuation
- Met any of exclusion criteria regarding medical/psychiatric status listed in the short-term trials ( 041021 or 041022)
- 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 Olanzapine Positive Control in Subjects Who Complete Protocols 041021 or 041022.
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 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
- Olanzapine, Asenapine, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
5- 20 mg QD
AsenapineDrug
5 or 10 mg BID
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Olanzapine 20 mg QD Receives: Drug: Olanzapine |
| 2 | Experimental | Asenapine 5 or 10 mg BID Receives: Drug: Asenapine |
| 3 | Other | Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041021 or 041022 asenapine trials, were randomized (double-blind) Into the long-term 041512 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: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess long-term safety including overall symptoms (AEs; SAEs); Vital signs; ISST; EPS; and maintenance of effect; for asenapine with haloperidol control.
Measured: Weeks 1;2; 4; 8; 12; 16; 24; 32; 40; 52 (Endpoint)
Quality of Life and Patient Functionality (QLS; Q-LES-Q and PETIT)
Measured: Weeks 16; 32; 52(Endpoint)
Secondary outcomes (6)
Pregnancy tests; Lab tests
Measured: Weeks 8; 16; 32; 52 (Endpoint)
Physical exams
Measured: Week 12; 24; 52 (Endpoint)
Neurocognition and cognitive functioning
Measured: Weeks 24 and 52 (Endpoint)
Weight and abdominal girth
Measured: Weeks 4;8;12; 16; 24; 32;40;52(Endpoint)
ECGs
Measured: Weeks 2;4;8;24;52(Endpoint)
Depression (CDSS)
Measured: Weeks 12; 24; 52 (Endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156091
- Sponsor's protocol ID
- P05784
- Other IDs
- Hera;, 41512
- Status last verified
- Feb 2022
- First submitted
- 8 Sep 2005
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 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 Olanzapine Positive Control in Subjects Who Complete Protocols 041021 or 041022.
- ClinicalTrials.gov ID
- NCT00156091
- Acronym / sponsor ID
- P05784
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
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 |
|---|---|---|
| 1 | Active comparator | Drug: OlanzapineOlanzapine 20 mg QD |
| 2 | Experimental | Drug: AsenapineAsenapine 5 or 10 mg BID |
| 3 | Other | Other: PlaceboDouble-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041021 or 041022 asenapine trials, were randomized (double-blind) Into the long-term 041512 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 trial ( 041021 or 021022)
- 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 041512 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 score of greater or equal to 6 ( severely psychotic)
- Occurrence(s) of AE or other clinically significant findings that would prohibit their continuation
- Met any of exclusion criteria regarding medical/psychiatric status listed in the short-term trials ( 041021 or 041022)
- 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 |
|---|---|---|
| Olanzapine5- 20 mg QD | Drug | 1 |
| Asenapine5 or 10 mg BID | Drug | 2 |
| Placebo | Other | 3 |
Primary outcome
To assess long-term safety including overall symptoms (AEs; SAEs); Vital signs; ISST; EPS; and maintenance of effect; for asenapine with haloperidol control.
Time frame: Weeks 1;2; 4; 8; 12; 16; 24; 32; 40; 52 (Endpoint)
Quality of Life and Patient Functionality (QLS; Q-LES-Q and PETIT)
Time frame: Weeks 16; 32; 52(Endpoint)
6 secondary outcomes
Pregnancy tests; Lab tests
Time frame: Weeks 8; 16; 32; 52 (Endpoint)
Physical exams
Time frame: Week 12; 24; 52 (Endpoint)
Neurocognition and cognitive functioning
Time frame: Weeks 24 and 52 (Endpoint)
Weight and abdominal girth
Time frame: Weeks 4;8;12; 16; 24; 32;40;52(Endpoint)
ECGs
Time frame: Weeks 2;4;8;24;52(Endpoint)
Depression (CDSS)
Time frame: Weeks 12; 24; 52 (Endpoint)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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 Olanzapine 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 16 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess long-term safety including overall symptoms (AEs; SAEs); Vital signs; ISST; EPS; and maintenance of effect; for asenapine with haloperidol control. (time frame: Weeks 1;2; 4; 8; 12; 16; 24; 32; 40; 52 (Endpoint)). 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?
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 16 Feb 2022.