Bipolar DisorderPhase 3NCT00159744
3-Week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07008)
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
- 488 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2004to 29 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 DSMIV diagnosis of bipolar I disorder, current episode manic or mixed.
Who cannot join
- Patients with unstable medical conditions or clinically significant laboratory abnormalities or patients who are rapid cyclers (ie. 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 7501004 (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. Patients will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Patients will be required to stay in the hospital for at least the first seven days of treatment. Patients that 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 | Active comparator | 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.
Changes in bipolar manic or mixed symptoms reflected in the scores on the YMRS (Young Mania Rating Scale)
Measured: The YMRS was administered at screening, baseline, Day 2, 4, 7, 14 and 21
Secondary outcomes (11)
Ratings on the Clinical Global Impression scale in which severity and improvement of mania, depression, and overall bipolar state are rated.
Measured: The CGI assessment at days 1,7 and endpoint (day 21 or the time of the last assessment).
The PANSS (Positive and Negative Symptom Scale) was used to assess psychotic symptoms
Measured: The PANSS was administered at Days 1, 7 and 21(or the time of the last assessment).
The MADRS (Montgomery Asberg Depression Rating Scale) was used to assess depressive symptoms
Measured: The MADRS was administered on Days 1, 7 and 21(or at the time of the last assessment).l
The Readiness for Discharge Questionaire (RDQ) was administered to characterize the subject's readiness for discharge. The investigator was to make the decision about discharging the subject.
Measured: The RDQ was administered on Day 1, 2, 4, 7 , 14 and 21 (or at the time of the last assessment)
CogState, cognition battery, was used to assess changes in cognition
Measured: Cog State was administered at screening, Day 1 (baseline) and Days 7, 14, 21 (or endpoint).
SF (short form)-36 and TSQM (Treatment Satisfaction Questionnaire for Medication) -- 2 measures of Quality of Life were administered.
Measured: The SF Health Survey was administered at Day 1 and Day 21 or endpoint. The TSMQ was administered at Day 21 or endpoint..
The SARS (Simpson Angus Rating Scale); the AIMS (Involuntary Movement Scale and the BARS (Barnes Akathisia Scale) were used to assess extrapyramidal symptoms
Measured: The SARS, AIMS and BARS assessments were administered at Days 1, 7 and 21 or endpoint.
Concomitant medication use was recorded
Measured: Concomitant medication use was recorded whenever it occurred
Physical examination, laboratory and electrocardiogram findings and weight/abdominal girth and vital signs were recorded.
Measured: Physical exam, ECG, laboratory and weight were recorded at screening and Day 21 or endpoint. Laboratory work was also done at baseline.
Adverse events (AEs)
Measured: AEs were recorded whenever they occurred..
Pharmacokinetic analysis was done to determine the level of the drug in the blood
Measured: Pk samples were taken at Day 1, 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 start30 Nov 2004
- Primary completion29 Apr 2006
- Study completion29 Apr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 488 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
- NCT00159744
- Sponsor's protocol ID
- P07008
- Other IDs
- A7501004
- Status last verified
- Feb 2022
- First submitted
- 8 Sep 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 in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord. 2010 Apr;122(1-2):27-38. doi: 10.1016/j.jad.2009.12.028. Epub 2010 Jan 22.
PubMed 20096936Suppes 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 7501004 (Secondary Title: ARES)
- ClinicalTrials.gov ID
- NCT00159744
- Acronym / sponsor ID
- P07008
- Conditions
- Bipolar Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 30 Nov 2004 (actual)
- Primary completion
- 29 Apr 2006 (actual)
- Study completion
- 29 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. Patients will receive either asenapine, olanzapine (a medication that is already approved for the treatment of bipolar mania), or placebo (no active medication). Patients will be required to stay in the hospital for at least the first seven days of treatment. Patients that 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 | Active comparator | 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 DSMIV diagnosis of bipolar I disorder, current episode manic or mixed.
Key exclusion criteria (1 listed)
- Patients with unstable medical conditions or clinically significant laboratory abnormalities or patients who are rapid cyclers (ie. 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
Changes in bipolar manic or mixed symptoms reflected in the scores on the YMRS (Young Mania Rating Scale)
Time frame: The YMRS was administered at screening, baseline, Day 2, 4, 7, 14 and 21
11 secondary outcomes
Ratings on the Clinical Global Impression scale in which severity and improvement of mania, depression, and overall bipolar state are rated.
Time frame: The CGI assessment at days 1,7 and endpoint (day 21 or the time of the last assessment).
The PANSS (Positive and Negative Symptom Scale) was used to assess psychotic symptoms
Time frame: The PANSS was administered at Days 1, 7 and 21(or the time of the last assessment).
The MADRS (Montgomery Asberg Depression Rating Scale) was used to assess depressive symptoms
Time frame: The MADRS was administered on Days 1, 7 and 21(or at the time of the last assessment).l
The Readiness for Discharge Questionaire (RDQ) was administered to characterize the subject's readiness for discharge. The investigator was to make the decision about discharging the subject.
Time frame: The RDQ was administered on Day 1, 2, 4, 7 , 14 and 21 (or at the time of the last assessment)
CogState, cognition battery, was used to assess changes in cognition
Time frame: Cog State was administered at screening, Day 1 (baseline) and Days 7, 14, 21 (or endpoint).
SF (short form)-36 and TSQM (Treatment Satisfaction Questionnaire for Medication) -- 2 measures of Quality of Life were administered.
Time frame: The SF Health Survey was administered at Day 1 and Day 21 or endpoint. The TSMQ was administered at Day 21 or endpoint..
The SARS (Simpson Angus Rating Scale); the AIMS (Involuntary Movement Scale and the BARS (Barnes Akathisia Scale) were used to assess extrapyramidal symptoms
Time frame: The SARS, AIMS and BARS assessments were administered at Days 1, 7 and 21 or endpoint.
Concomitant medication use was recorded
Time frame: Concomitant medication use was recorded whenever it occurred
Physical examination, laboratory and electrocardiogram findings and weight/abdominal girth and vital signs were recorded.
Time frame: Physical exam, ECG, laboratory and weight were recorded at screening and Day 21 or endpoint. Laboratory work was also done at baseline.
Adverse events (AEs)
Time frame: AEs were recorded whenever they occurred..
Pharmacokinetic analysis was done to determine the level of the drug in the blood
Time frame: Pk samples were taken at Day 1, 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.
- Results publication: PubMed 20096936McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord. 2010 Apr;122(1-2):27-38. doi: 10.1016/j.jad.2009.12.028. Epub 2010 Jan 22.
- 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.
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. 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?
Changes in bipolar manic or mixed symptoms reflected in the scores on the YMRS (Young Mania Rating Scale) (time frame: The YMRS was administered at screening, baseline, Day 2, 4, 7, 14 and 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 NCT00159744, which also lists 4 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.