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| ID | Type | Description | Link |
|---|---|---|---|
| A7501005 | Other Identifier | Schering-Plough |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Asenapine |
|
| Arm 2 | Active Comparator | Olanzapine |
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| Arm 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine | Drug | Asenapine, 3 weeks |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Day 21 on the Young Mania Rating Scale (YMRS) Total Score | Baseline to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Day 21 in the Clinical Global Impression Scale for use in Bipolar Disorder (CGI-BP) Severity of Mania | Baseline to Day 21 | |
| Change from Baseline to Day 21 in the Positive and Negative Symptom Scale (PANSS) Total Score | Baseline to Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29105003 | Derived | 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. | |
| 24329543 | Derived | Michalak 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. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Olanzapine |
| Drug |
Olanzapine, 3 weeks |
|
| Placebo | Drug | placebo, 3 weeks |
|
| Change from Baseline to Day 21 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score | Baseline to Day 21 |
| Readiness for Discharge Questionnaire (RDQ) | Baseline to Day 21 |
| Change from Baseline to Day 21 in Central Nervous System (CNS) Vital Signs | Baseline to Day 21 |
| Change from Baseline to Day 21 in Short Form-36 (SF-36) - Physical Component Summary Scores | Baseline to Day 21 |
| Change from Baseline to Day 21 in the Severity of Extrapyramidal Symptoms (EPS) | Baseline to Day 21 |
| Concomitant Medication Usage | Up to Day 21 |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 30 days after last dose (Up to approximately 51 days) |
| Change from Baseline to Each Time Point in YMRS Total Score | Days 2, 4, 7, 14, and 21 |
| Change from Baseline to Day 21 in the CGI-BP Severity of Depression | Baseline to Day 21 |
| Change from Baseline to Day 21 in the CGI-BP Severity of Overall Bipolar Illness | Baseline to Day 21 |
| Change from Baseline to Day 21 in SF-36 - Mental Component Summary Scores | Baseline to Day 21 |
| Treatment Satisfaction Questionnaire for Medicine (TSQM) Overall Impact Domain Score at Day 21 | Day 21 |
| Mean Change from Baseline for Vital Signs | Baseline up to Day 21 |
| Change from Baseline to Day 21 in Body Weight | Baseline to Day 21 |
| Summary of Post-Baseline Markedly Abnormal Biochemistry Laboratory Changes/Values | Up to Day 21 |
| Summary of Post-Baseline Markedly Abnormal Endocrinology/Miscellaneous Laboratory Changes/Values | Up to Day 21 |
| Summary of Post-Baseline Markedly Abnormal Metabolic Chemistry Laboratory Changes/Values | Up to Day 21 |
| Summary of Post-Baseline Markedly Abnormal Hematology Laboratory Values | Up to Day 21 |
| Pharmacokinetics - Plasma asenapine concentrations | Day 1 (pre-dose), 7, 14 and 21 (or endpoint) |
| 23473546 | Derived | Szegedi 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. |
| D006571 | Heterocyclic Compounds |