Bipolar DisorderPhase 3NCT00159796
3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)
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?
- Yes, some participants may receive a placebo
- How many people
- 489 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2004to 28 Apr 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 a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.
Who cannot join
- Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder as a primary diagnosis.
About this study
Official title: A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Safety and Efficacy of Sublingual Asenapine vs. Olanzapine and Placebo in In-Patients With an Acute Manic Episode Clinical Trial Protocol 7501005 (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. This is a 3-week study that will test the safety and efficacy of this medication. Participants will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Participants will be required to stay in the hospital for at least the first seven days of treatment. Participants who complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.
- Conditions
- Bipolar Disorder
- Being tested
- Asenapine, Olanzapine, Placebo
- 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, 3 weeks
OlanzapineDrug
Olanzapine, 3 weeks
PlaceboDrug
placebo, 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Asenapine Receives: Drug: Asenapine |
| Arm 2 | Active comparator | Olanzapine Receives: Drug: Olanzapine |
| Arm 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score
Measured: Baseline to Day 21
Secondary outcomes (21)
Change from Baseline to Day 21 in the Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) Severity of Mania
Measured: Baseline to Day 21
Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score
Measured: Baseline to Day 21
Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Measured: Baseline to Day 21
Readiness for Discharge Questionnaire (RDQ)
Measured: Baseline to Day 21
Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs
Measured: Baseline to Day 21
Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores
Measured: Baseline to Day 21
Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS)
Measured: Baseline to Day 21
Concomitant Medication Usage
Measured: Up to Day 21
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to 30 days after last dose (Up to approximately 51 days)
Change from Baseline to Each Time Point in YMRS Total Score
Measured: Days 2, 4, 7, 14, and 21
Change from Baseline to Day 21 in the CGI-BP Severity of Depression
Measured: Baseline to Day 21
Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness
Measured: Baseline to Day 21
Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores
Measured: Baseline to Day 21
Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21
Measured: Day 21
Mean Change from Baseline for Vital Signs
Measured: Baseline up to Day 21
Change from Baseline to Day 21 in Body Weight
Measured: Baseline to Day 21
Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values
Measured: Up to Day 21
Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values
Measured: Up to Day 21
Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values
Measured: Up to Day 21
Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values
Measured: Up to Day 21
Pharmacokinetics - Plasma asenapine concentrations
Measured: Day 1 (pre-dose), 7, 14 and 21 (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 start14 Dec 2004
- Primary completion28 Mar 2006
- Study completion28 Apr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159796
- Sponsor's protocol ID
- P07009
- Other IDs
- A7501005
- Status last verified
- Feb 2022
- First submitted
- 8 Sep 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suppes T, Eberhard J, Lemming O, Young AH, McIntyre RS. Anxiety, irritability, and agitation as indicators of bipolar mania with depressive symptoms: a post hoc analysis of two clinical trials. Int J Bipolar Disord. 2017 Nov 6;5(1):36. doi: 10.1186/s40345-017-0103-7.
PubMed 29105003Michalak EE, Guiraud-Diawara A, Sapin C. Asenapine treatment and health-related quality of life in patients experiencing bipolar I disorder with mixed episodes: post-hoc analyses of pivotal trials. Curr Med Res Opin. 2014 Apr;30(4):711-8. doi: 10.1185/03007995.2013.874988. Epub 2014 Jan 10.
PubMed 24329543Szegedi A, Zhao J, McIntyre RS. Early improvement as a predictor of acute treatment outcome in manic or mixed episodes in bipolar-1 disorder: a pooled, post hoc analysis from the asenapine development program. J Affect Disord. 2013 Sep 25;150(3):745-52. doi: 10.1016/j.jad.2013.01.024. Epub 2013 Mar 6.
PubMed 23473546
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, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Safety and Efficacy of Sublingual Asenapine vs. Olanzapine and Placebo in In-Patients With an Acute Manic Episode Clinical Trial Protocol 7501005 (Secondary Title: ARES)
- ClinicalTrials.gov ID
- NCT00159796
- Acronym / sponsor ID
- P07009
- Conditions
- Bipolar Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 14 Dec 2004 (actual)
- Primary completion
- 28 Mar 2006 (actual)
- Study completion
- 28 Apr 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.
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. This is a 3-week study that will test the safety and efficacy of this medication. Participants will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Participants will be required to stay in the hospital for at least the first seven days of treatment. Participants who complete the 3 week study may be eligible to continue in extension studies for an additional 9 (study A7501006) to 49 (study A7501007) weeks.
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 |
|---|---|---|
| Arm 1 | Experimental | Drug: AsenapineAsenapine |
| Arm 2 | Active comparator | Drug: OlanzapineOlanzapine |
| Arm 3 | Placebo comparator | Drug: PlaceboPlacebo |
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 a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bipolar I disorder, current episode manic or mixed.
Key exclusion criteria (1 listed)
- Participants with unstable medical conditions or clinically significant laboratory abnormalities or participants who are rapid cyclers (i.e., have had 4 or more (including current) mood episodes in the past 12 months); have any other psychiatric disorder other than bipolar I disorder 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 |
|---|---|---|
| AsenapineAlso: Org 5222Asenapine, 3 weeks | Drug | Arm 1 |
| OlanzapineOlanzapine, 3 weeks | Drug | Arm 2 |
| Placeboplacebo, 3 weeks | Drug | Arm 3 |
Primary outcome
Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score
Time frame: Baseline to Day 21
21 secondary outcomes
Change from Baseline to Day 21 in the Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) Severity of Mania
Time frame: Baseline to Day 21
Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score
Time frame: Baseline to Day 21
Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline to Day 21
Readiness for Discharge Questionnaire (RDQ)
Time frame: Baseline to Day 21
Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs
Time frame: Baseline to Day 21
Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores
Time frame: Baseline to Day 21
Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS)
Time frame: Baseline to Day 21
Concomitant Medication Usage
Time frame: Up to Day 21
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 30 days after last dose (Up to approximately 51 days)
Change from Baseline to Each Time Point in YMRS Total Score
Time frame: Days 2, 4, 7, 14, and 21
Change from Baseline to Day 21 in the CGI-BP Severity of Depression
Time frame: Baseline to Day 21
Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness
Time frame: Baseline to Day 21
Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores
Time frame: Baseline to Day 21
Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21
Time frame: Day 21
Mean Change from Baseline for Vital Signs
Time frame: Baseline up to Day 21
Change from Baseline to Day 21 in Body Weight
Time frame: Baseline to Day 21
Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values
Time frame: Up to Day 21
Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values
Time frame: Up to Day 21
Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values
Time frame: Up to Day 21
Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values
Time frame: Up to Day 21
Pharmacokinetics - Plasma asenapine concentrations
Time frame: Day 1 (pre-dose), 7, 14 and 21 (or 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 29105003Suppes T, Eberhard J, Lemming O, Young AH, McIntyre RS. Anxiety, irritability, and agitation as indicators of bipolar mania with depressive symptoms: a post hoc analysis of two clinical trials. Int J Bipolar Disord. 2017 Nov 6;5(1):36. doi: 10.1186/s40345-017-0103-7.
- Derived from this study: PubMed 24329543Michalak EE, Guiraud-Diawara A, Sapin C. Asenapine treatment and health-related quality of life in patients experiencing bipolar I disorder with mixed episodes: post-hoc analyses of pivotal trials. Curr Med Res Opin. 2014 Apr;30(4):711-8. doi: 10.1185/03007995.2013.874988. Epub 2014 Jan 10.
- Derived from this study: PubMed 23473546Szegedi A, Zhao J, McIntyre RS. Early improvement as a predictor of acute treatment outcome in manic or mixed episodes in bipolar-1 disorder: a pooled, post hoc analysis from the asenapine development program. J Affect Disord. 2013 Sep 25;150(3):745-52. doi: 10.1016/j.jad.2013.01.024. Epub 2013 Mar 6.
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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.
Medical Director study director
Merck Sharp & Dohme LLC
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. 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 from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score (time frame: Baseline to Day 21). 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 NCT00159796, which also lists 3 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.