Bipolar DisorderPhase 3NCT00159783
40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)
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 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
- 218 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Apr 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
- Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..
Who cannot join
- Patients with unstable medical conditions or clinically significant laboratory
- abnormalities.
About this study
Official title: A Double-Blind, 40-Week Continuation Study Evaluating the Safety of Asenapine and Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501007 (Secondary Title: ARES)
Bipolar disorder is characterized by mood swings that range from 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 study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.
- 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, 40 weeks
OlanzapineDrug
Olanzapine, 40 weeks
| Study group | Role | What they receive |
|---|---|---|
| Asenapine | Experimental | Asenapine 5-10 mg twice daily for 40 weeks Receives: Drug: asenapine |
| Olanzapine | Active comparator | Olanzapine 5-20 mg once daily for 40 weeks Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Who Experienced Adverse Event(s)
Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment.
An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Measured: Up to 40 weeks
Number of Participants With Abnormal Physical Examination Findings
Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm \& rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.
Measured: Week 40 or endpoint
Number of Participants With Abnormal Electrocardiogram
This is the number of participants with electrocardiogram (ECG) adverse events.
Measured: Week 40 or endpoint
Body Weight
Weight change from baseline
Measured: Baseline to Week 40 or endpoint
Extrapyramidal Symptoms [EPS]
EPS was assessed using the (1) involuntary movement scale [AIMS], (2) Barnes Akathisia Rating Scale [BARS], and (3) Simpson Angus Rating Scale SARS.
AIMS score range 0-4; higher scores indicate greater symptom severity.
BARS score rang 0-9; higher scores indicate greater severity of akathisia.
SARS score range 0-40; higher scores indicate greater degree of Parkinsonism.
Measured: Week 40 or endpoint
Concomitant Medications
Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of
last dose of double-blind study drug.
Measured: Up to 40 weeks
Abdominal Girth
Change in abdominal girth from baseline
Measured: Baseline to Week 40 or endpoint
Number of Participants With Markedly Abnormal Vital Sign Changes
Vital signs measured: sitting blood pressure, heart rate.
Definitions:
Markedly abnormal decreases: heart rate (HR) - if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) - if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) - if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.
Markedly abnormal increases: HR - if ≥110 bpm and increase from baseline of ≥15 bpm; SBP - if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP - if ≥105 mm Hg and increase from baseline of ≥15 mm Hg.
Measured: Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)
Number of Participants With Laboratory Values Outside Normal Range
Normal ranges were provided by the central laboratory.
Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin
Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin
Endocrinology/miscellaneous = insulin, prolactin
Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils
Measured: Week 40 or 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 startJul 2005
- Primary completionApr 2007
- Study completionApr 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.
- 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
- 218 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
- NCT00159783
- Sponsor's protocol ID
- P05857
- Other IDs
- A7501007
- Status last verified
- Feb 2022
- First submitted
- 8 Sep 2005
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord. 2010 Nov;126(3):358-65. doi: 10.1016/j.jad.2010.04.005.
PubMed 20537396
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, 40-Week Continuation Study Evaluating the Safety of Asenapine and Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501007 (Secondary Title: ARES)
- ClinicalTrials.gov ID
- NCT00159783
- Acronym / sponsor ID
- P05857
- Conditions
- Bipolar Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jul 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 16 Jul 2010
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 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 study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.
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 |
|---|---|---|
| Asenapine | Experimental | Drug: asenapineAsenapine 5-10 mg twice daily for 40 weeks |
| Olanzapine | Active comparator | Drug: OlanzapineOlanzapine 5-20 mg once daily for 40 weeks |
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 asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..
Key exclusion criteria (2 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, 40 weeks | Drug | Asenapine |
| OlanzapineOlanzapine, 40 weeks | Drug | Olanzapine |
Primary outcome
Participants Who Experienced Adverse Event(s)
Time frame: Up to 40 weeks
Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Number of Participants With Abnormal Physical Examination Findings
Time frame: Week 40 or endpoint
Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm \& rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.
Number of Participants With Abnormal Electrocardiogram
Time frame: Week 40 or endpoint
This is the number of participants with electrocardiogram (ECG) adverse events.
Body Weight
Time frame: Baseline to Week 40 or endpoint
Weight change from baseline
Extrapyramidal Symptoms [EPS]
Time frame: Week 40 or endpoint
EPS was assessed using the (1) involuntary movement scale [AIMS], (2) Barnes Akathisia Rating Scale [BARS], and (3) Simpson Angus Rating Scale SARS. AIMS score range 0-4; higher scores indicate greater symptom severity. BARS score rang 0-9; higher scores indicate greater severity of akathisia. SARS score range 0-40; higher scores indicate greater degree of Parkinsonism.
Concomitant Medications
Time frame: Up to 40 weeks
Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of last dose of double-blind study drug.
Abdominal Girth
Time frame: Baseline to Week 40 or endpoint
Change in abdominal girth from baseline
Number of Participants With Markedly Abnormal Vital Sign Changes
Time frame: Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)
Vital signs measured: sitting blood pressure, heart rate. Definitions: Markedly abnormal decreases: heart rate (HR) - if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) - if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) - if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg. Markedly abnormal increases: HR - if ≥110 bpm and increase from baseline of ≥15 bpm; SBP - if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP - if ≥105 mm Hg and increase from baseline of ≥15 mm Hg.
Number of Participants With Laboratory Values Outside Normal Range
Time frame: Week 40 or endpoint
Normal ranges were provided by the central laboratory. Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin Endocrinology/miscellaneous = insulin, prolactin Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20537396McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord. 2010 Nov;126(3):358-65. doi: 10.1016/j.jad.2010.04.005.
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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 2 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 9 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 16 Jul 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?
Participants Who Experienced Adverse Event(s) (time frame: Up to 40 weeks). The study lists 9 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 NCT00159783, 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 9 Feb 2022.