Bipolar DisorderPhase 3NCT00143182
9 Week Extension Study of Asenapine and Olanzapine in Treatment of Mania (P07007)(COMPLETED)
A Phase 3 study testing Asenapine and Olanzapine in people with Bipolar Disorder, run by Organon and Co.
Trial summary
Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Asenapine and Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2005to 28 Jun 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
- Have completed an asenapine 3-week study for the treatment of an acute manic or mixed episode and not had a major protocol violation.in the short term study (A7501004 or A7501005) that they completed.
Who cannot join
- Patients with unstable medical conditions or clinically significant laboratory abnormalities.
About this study
Official title: A Double-Blind, 9-Week Extension Study Evaluating the Safety and Maintenance of Effect of Asenapine vs. Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501006 (Secondary Title: ARES)
Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.
- Conditions
- Bipolar Disorder
- Being tested
- Asenapine, Olanzapine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsenapineDrug
Also called Org 5222
Asenapine , 9 weeks
OlanzapineDrug
Olanzapine, 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Asenapine Receives: Drug: Asenapine |
| 2 | Active comparator | Olanzapine Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of the effect (Asenapine comparable to olanzapine in terms of the reduction of symptoms achieved in the short term (ie. 3 week studies [A7501004 or A7501005]) as measured on the Young Mania Rating Scale
Measured: The YMRS is administered at weeks 1, 3, 6 and 9 or endpoint.
Secondary outcomes (7)
Changes on the Clinical Global Impression Scale in which Mania, Depression and Overall Status were assessed.
Measured: The Global assessment at Weeks 1,3, 6 and 9 or endpoint
Improvement in symptoms of depression (measured by the Montgomery Asberg Rating Scale of Depression - the MADRS), psychoses (Positive and Negative Symptoms Scale -- the PANSS) and suicidality (ISST-- The InsterSept Suicidality Scale)
Measured: PANSS and MADRS administered at weeks 1,3,6 and 9 or endpoint; ISST administered at Weeks 1 and 6.
Changes in the Quality of Life and the TSQM and changes in Readiness to Discharge Questionaire [RDQ]. The investigator's judgment was the basis for a decision to discharge the subject from the hospital.
Measured: Quality of Life measures were administered at week 9 or endpoint and the RDQ was administered to inpatients at week 1, 3, 6 and 9.or endpoint.
Physical exams and electrocardiograms findings; changes in vital signs, weight and abdominal girth and hematology and urinalysis.
Measured: Physical exams and ECGs at Week 9 or endpoint; Vital signs, weight and abdominal girth at weeks 1, 3, 6 and 9 or endpoint; hematological parameters assessed at weeks 1 and 9 or endpoint; urinalysis was done at Week 9 or endpoint.
Cognition -- the cognitive battery was the same battery that the subject had in the short term study in which they participated -- CNS Vital Signs for A7501005 and Cogstate for A7501004.
Measured: The cognitive battery was done at Week 9 or endpoint
Extrapyramidal symptoms were assessed using the AIMS (Involuntary Movement Scale); the BARS (Barnes Akathisia Rating Scale) and the SARS (Simpson Angus Rating Scale).
Measured: Extrapyramidal symptoms were assessed at Week 9 or endpoint.
Adverse events and concomitant medications were recorded
Measured: Recorded at each visit (Weeks 1, 3, 6, 9 and endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study start7 Jan 2005
- Primary completion28 Jun 2006
- Study completion28 Jun 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 Bipolar DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143182
- Sponsor's protocol ID
- P07007
- Other IDs
- A7501006
- Status last verified
- Feb 2022
- First submitted
- 31 Aug 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord. 2009 Dec;11(8):815-26. doi: 10.1111/j.1399-5618.2009.00749.x. Epub 2009 Oct 14.
PubMed 19832806
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 Double-Blind, 9-Week Extension Study Evaluating the Safety and Maintenance of Effect of Asenapine vs. Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501006 (Secondary Title: ARES)
- ClinicalTrials.gov ID
- NCT00143182
- Acronym / sponsor ID
- P07007
- Conditions
- Bipolar Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 7 Jan 2005 (actual)
- Primary completion
- 28 Jun 2006 (actual)
- Study completion
- 28 Jun 2006 (actual)
- First posted
- 2 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.
Bipolar disorder is characterized by mood swings that range from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed the 3 week trial (A7601004 or A7501005) continued on the same treatment that they received in the short term study: asenapine or olanzapine (a medication already approved for the treatment of bipolar mania) for 9 additional weeks. The short term studies (A7501004 and A7501005) were not unblinded until the 9 week extension study was unblinded. Patients treated with placebo in the 3 week short term study were crossed over and treated with Asenapine in the 9 week extension study. Patients who complete the 9 week extension study were eligible to continue in another extension (A7501007) study for an additional 40 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AsenapineAsenapine |
| 2 | Active comparator | Drug: OlanzapineOlanzapine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have completed an asenapine 3-week study for the treatment of an acute manic or mixed episode and not had a major protocol violation.in the short term study (A7501004 or A7501005) that they completed.
Key exclusion criteria (1 listed)
- Patients with unstable medical conditions or clinically significant laboratory abnormalities.
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 5222Asenapine , 9 weeks | Drug | 1 |
| OlanzapineOlanzapine, 9 weeks | Drug | 2 |
Primary outcome
Maintenance of the effect (Asenapine comparable to olanzapine in terms of the reduction of symptoms achieved in the short term (ie. 3 week studies [A7501004 or A7501005]) as measured on the Young Mania Rating Scale
Time frame: The YMRS is administered at weeks 1, 3, 6 and 9 or endpoint.
7 secondary outcomes
Changes on the Clinical Global Impression Scale in which Mania, Depression and Overall Status were assessed.
Time frame: The Global assessment at Weeks 1,3, 6 and 9 or endpoint
Improvement in symptoms of depression (measured by the Montgomery Asberg Rating Scale of Depression - the MADRS), psychoses (Positive and Negative Symptoms Scale -- the PANSS) and suicidality (ISST-- The InsterSept Suicidality Scale)
Time frame: PANSS and MADRS administered at weeks 1,3,6 and 9 or endpoint; ISST administered at Weeks 1 and 6.
Changes in the Quality of Life and the TSQM and changes in Readiness to Discharge Questionaire [RDQ]. The investigator's judgment was the basis for a decision to discharge the subject from the hospital.
Time frame: Quality of Life measures were administered at week 9 or endpoint and the RDQ was administered to inpatients at week 1, 3, 6 and 9.or endpoint.
Physical exams and electrocardiograms findings; changes in vital signs, weight and abdominal girth and hematology and urinalysis.
Time frame: Physical exams and ECGs at Week 9 or endpoint; Vital signs, weight and abdominal girth at weeks 1, 3, 6 and 9 or endpoint; hematological parameters assessed at weeks 1 and 9 or endpoint; urinalysis was done at Week 9 or endpoint.
Cognition -- the cognitive battery was the same battery that the subject had in the short term study in which they participated -- CNS Vital Signs for A7501005 and Cogstate for A7501004.
Time frame: The cognitive battery was done at Week 9 or endpoint
Extrapyramidal symptoms were assessed using the AIMS (Involuntary Movement Scale); the BARS (Barnes Akathisia Rating Scale) and the SARS (Simpson Angus Rating Scale).
Time frame: Extrapyramidal symptoms were assessed at Week 9 or endpoint.
Adverse events and concomitant medications were recorded
Time frame: Recorded at each visit (Weeks 1, 3, 6, 9 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.
- Derived from this study: PubMed 19832806McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord. 2009 Dec;11(8):815-26. doi: 10.1111/j.1399-5618.2009.00749.x. Epub 2009 Oct 14.
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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 Bipolar 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?
Maintenance of the effect (Asenapine comparable to olanzapine in terms of the reduction of symptoms achieved in the short term (ie. 3 week studies [A7501004 or A7501005]) as measured on the Young Mania Rating Scale (time frame: The YMRS is administered at weeks 1, 3, 6 and 9 or 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 NCT00143182, 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.