SchizophreniaPhase 3NCT00156117
Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)
A Phase 3 study testing asenapine and olanzapine 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?
- asenapine and olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2005to 30 May 2006
- 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
- Currently suffering from an acute exacerbation of schizophrenia. Caregiver required.
Who cannot join
- Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine Positive Control in Subjects With an Acute Exacerbation of Schizophrenia
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.
Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.
- Conditions
- Schizophrenia
- Being tested
- asenapine, Placebo, 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 mg BID or 10mg BID
PlaceboDrug
Placebo
olanzapineDrug
olanzapine 15 mg QD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | asenapine 5 mg BID and 10 mg BID Receives: Drug: asenapine |
| 2 | Placebo comparator | Placebo against olanzapine and asenapine Receives: Drug: Placebo |
| 3 | Active comparator | olanzapine 15 mgQD Receives: Drug: olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline
Measured: Screen, baseline, Days 4,7,14,21,28,35,42
Secondary outcomes (14)
Changes in PANSS subscale and Marder factor scores; CGI-S scores
Measured: Screen, baseline, Days 4,7,14,21,28,35,42
CGI-I scores
Measured: Days 4,7,14,21,28,35,42
Neurocognition and cognitive functioning
Measured: Baseline , day 42
Anxiety
Measured: Baseline, day 42
Suicidal thinking
Measured: Baseline, day 42
Quality of life and patient functionality
Measured: Baseline, day 42
Readiness to discharge, at scheduled assessments and endpoint from baseline
Measured: Baseline up to day 14
Extrapyramidal symptoms
Measured: Baseline, Days 4,7,14,21,28,35,42
Laboratory parameters
Measured: Baseline, Days 14,,28,,42
Vital signs
Measured: Baseline, Days ,14,21,28,42
Weight
Measured: Baseline, Days 14,,28,,42
ECGs
Measured: Baseline, Days ,14,,28,,42
Adverse events (including serious adverse events)
Measured: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 7 days after endpoint
SAEs up to 30 days after endpoint
Measured: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 30 days after 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 start12 May 2005
- Primary completion28 Apr 2006
- Study completion30 May 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 417 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
- NCT00156117
- Sponsor's protocol ID
- P05933
- Other IDs
- Hera, 41021
- Status last verified
- Feb 2022
- First submitted
- 8 Sep 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Szegedi A, Verweij P, van Duijnhoven W, Mackle M, Cazorla P, Fennema H. Meta-analyses of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other antipsychotics. J Clin Psychiatry. 2012 Dec;73(12):1533-40. doi: 10.4088/JCP.11r07596.
PubMed 23290326Castle DJ, Slott Jensen JK. Management of depressive symptoms in schizophrenia. Clin Schizophr Relat Psychoses. 2015 Apr;9(1):13-20.
PubMed 25367164
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine Positive Control in Subjects With an Acute Exacerbation of Schizophrenia
- ClinicalTrials.gov ID
- NCT00156117
- Acronym / sponsor ID
- P05933
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 12 May 2005 (actual)
- Primary completion
- 28 Apr 2006 (actual)
- Study completion
- 30 May 2006 (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.
Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year 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 | Experimental | Drug: asenapineasenapine 5 mg BID and 10 mg BID |
| 2 | Placebo comparator | Drug: PlaceboPlacebo against olanzapine and asenapine |
| 3 | Active comparator | Drug: olanzapineolanzapine 15 mgQD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently suffering from an acute exacerbation of schizophrenia. Caregiver required.
Key exclusion criteria (1 listed)
- Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.
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 mg BID or 10mg BID | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
| olanzapineolanzapine 15 mg QD | Drug | 3 |
Primary outcome
Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline
Time frame: Screen, baseline, Days 4,7,14,21,28,35,42
14 secondary outcomes
Changes in PANSS subscale and Marder factor scores; CGI-S scores
Time frame: Screen, baseline, Days 4,7,14,21,28,35,42
CGI-I scores
Time frame: Days 4,7,14,21,28,35,42
Neurocognition and cognitive functioning
Time frame: Baseline , day 42
Anxiety
Time frame: Baseline, day 42
Suicidal thinking
Time frame: Baseline, day 42
Quality of life and patient functionality
Time frame: Baseline, day 42
Readiness to discharge, at scheduled assessments and endpoint from baseline
Time frame: Baseline up to day 14
Extrapyramidal symptoms
Time frame: Baseline, Days 4,7,14,21,28,35,42
Laboratory parameters
Time frame: Baseline, Days 14,,28,,42
Vital signs
Time frame: Baseline, Days ,14,21,28,42
Weight
Time frame: Baseline, Days 14,,28,,42
ECGs
Time frame: Baseline, Days ,14,,28,,42
Adverse events (including serious adverse events)
Time frame: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 7 days after endpoint
SAEs up to 30 days after endpoint
Time frame: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 30 days after 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 15 Aug 2024.
- Results publication: PubMed 23290326Szegedi A, Verweij P, van Duijnhoven W, Mackle M, Cazorla P, Fennema H. Meta-analyses of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other antipsychotics. J Clin Psychiatry. 2012 Dec;73(12):1533-40. doi: 10.4088/JCP.11r07596.
- Derived from this study: PubMed 25367164Castle DJ, Slott Jensen JK. Management of depressive symptoms in schizophrenia. Clin Schizophr Relat Psychoses. 2015 Apr;9(1):13-20.
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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 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 1 inclusion and 1 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 15 Aug 2024. 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?
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?
Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline (time frame: Screen, baseline, Days 4,7,14,21,28,35,42). 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 NCT00156117, which also lists 2 linked publications.
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 15 Aug 2024.