SchizophreniaPhase 3NCT00212784
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
A Phase 3 study testing asenapine and olanzapine in people with Schizophrenia and Schizoaffective Disorder, run by Organon and Co.
Trial summary
The primary features of schizophrenia and schizoaffective disorder are characterized by positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- 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
- 1,225 participants
- Where
- No sites listed yet
- Study dates
- 4 Sep 2003to 15 Mar 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
- Subject with schizophrenia or schizoaffective disorder. Subject must sign a written informed consent.
Who cannot join
- Have an uncontrolled, unstable, clinically significant medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
About this study
Official title: A Phase III, Double-Blind, Randomized, Active-Controlled, Two-Armed, Multicenter, Efficacy and Safety Assessment (ACTAMESA) of Org 5222 and Olanzapine in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
The primary features of schizophrenia and schizoaffective disorder are characterized by positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- asenapine, olanzapine
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asenapineDrug
Also called Org 5222, SCH 900274
Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.
olanzapineDrug
Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: asenapine |
| Arm 2 | 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 in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline
Measured: Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)
Secondary outcomes (14)
Changes in PANSS subscale scores and Marder factor scores
Measured: At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint
Changes in CGI-S
Measured: At each assessment time point from baseline
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)
Measured: At weeks 8, 20, 28, 36, 44 and endpoint
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)
Measured: At weeks 6, 28 and endpoint
Resource utilization (as measured by frequency and length of hospital stay)
Measured: During the study period
Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)
Measured: At endpoint
Population kinetics
Measured: Plasma samples at weeks 2 and 6 in comparison with baseline
Pharmacogenetics (as part of a global effort to investigate possible associations between genetic polymorphisms in relation to response to asenapine and related drugs and in relation to characteristics of schizophrenia and related conditions)
Measured: During the study period
Safety and tolerability: EPS (AIMS, BARS, SARS)
Measured: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Adverse Events
Measured: continuously and up to 7 days after endpoint
Pregnancy Test
Measured: At endpoint
Blood Test
Measured: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Weight and vital signs
Measured: at all assessment time points from baseline
ECGs
Measured: Weeks 3, 6, 24, and endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study start4 Sep 2003
- Primary completion15 Mar 2006
- Study completion15 Mar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,225 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
- NCT00212784
- Sponsor's protocol ID
- P05935
- Other IDs
- ACTAMESA, 25517
- Status last verified
- Feb 2022
- First submitted
- 13 Sep 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schoemaker J, Naber D, Vrijland P, Panagides J, Emsley R. Long-term assessment of Asenapine vs. Olanzapine in patients with schizophrenia or schizoaffective disorder. Pharmacopsychiatry. 2010 Jun;43(4):138-46. doi: 10.1055/s-0030-1248313. Epub 2010 Mar 4.
PubMed 20205074
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 Phase III, Double-Blind, Randomized, Active-Controlled, Two-Armed, Multicenter, Efficacy and Safety Assessment (ACTAMESA) of Org 5222 and Olanzapine in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00212784
- Acronym / sponsor ID
- P05935
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,225 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2003 (actual)
- Primary completion
- 15 Mar 2006 (actual)
- Study completion
- 15 Mar 2006 (actual)
- First posted
- 21 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.
The primary features of schizophrenia and schizoaffective disorder are characterized by positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: asenapine |
| Arm 2 | 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 (1 listed)
- Subject with schizophrenia or schizoaffective disorder. Subject must sign a written informed consent.
Key exclusion criteria (1 listed)
- Have an uncontrolled, unstable, clinically significant medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
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 |
|---|---|---|
| asenapineAlso: Org 5222, SCH 900274Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo. | Drug | Arm 1 |
| olanzapineOral capsules (5 mg or placebo); 1 to 2 tablets twice daily | Drug | Arm 2 |
Primary outcome
Change in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline
Time frame: Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)
14 secondary outcomes
Changes in PANSS subscale scores and Marder factor scores
Time frame: At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint
Changes in CGI-S
Time frame: At each assessment time point from baseline
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)
Time frame: At weeks 8, 20, 28, 36, 44 and endpoint
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)
Time frame: At weeks 6, 28 and endpoint
Resource utilization (as measured by frequency and length of hospital stay)
Time frame: During the study period
Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)
Time frame: At endpoint
Population kinetics
Time frame: Plasma samples at weeks 2 and 6 in comparison with baseline
Pharmacogenetics (as part of a global effort to investigate possible associations between genetic polymorphisms in relation to response to asenapine and related drugs and in relation to characteristics of schizophrenia and related conditions)
Time frame: During the study period
Safety and tolerability: EPS (AIMS, BARS, SARS)
Time frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Adverse Events
Time frame: continuously and up to 7 days after endpoint
Pregnancy Test
Time frame: At endpoint
Blood Test
Time frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Weight and vital signs
Time frame: at all assessment time points from baseline
ECGs
Time frame: Weeks 3, 6, 24, and 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 20205074Schoemaker J, Naber D, Vrijland P, Panagides J, Emsley R. Long-term assessment of Asenapine vs. Olanzapine in patients with schizophrenia or schizoaffective disorder. Pharmacopsychiatry. 2010 Jun;43(4):138-46. doi: 10.1055/s-0030-1248313. Epub 2010 Mar 4.
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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 and Schizoaffective Disorder, 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. 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 (52-week double-blind or last assessment after baseline) from baseline (time frame: Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)). 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 NCT00212784, 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 15 Aug 2024.