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| ID | Type | Description | Link |
|---|---|---|---|
| A7501009 |
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The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine | Active Comparator | Asenapine |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine | Drug | Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events). | up to 52 weeks |
| Number of Participants Who Discontinued Because of an Adverse Event | Participants who discontinued study medication due to adverse events. | 40 weeks |
| Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score | The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms. | Baseline and 52 Weeks |
| Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score | The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms. | Baseline and 52 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22198448 | Result | Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012 Feb;32(1):46-55. doi: 10.1097/JCP.0b013e31823f872f. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine | Asenapine 5 or 10 mg sublingually twice daily (BID) |
| FG001 | Placebo | Placebo sublingually BID |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine | Asenapine 5 or 10 mg sublingually twice daily (BID) |
| BG001 | Placebo | Placebo sublingually BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced an Adverse Event | Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events). | Posted | Number | Participants | up to 52 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Asenapine | Asenapine 5 or 10 mg sublingually twice daily (BID) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INTENTIONAL OVERDOSE | Injury, poisoning and procedural complications | 1008:9.1/10, 1009:11 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| 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 |
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| Placebo | Drug | Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks |
|
| Lost to Follow-up |
|
| Withdrew Consent |
|
| Reason not provided |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants Who Discontinued Because of an Adverse Event | Participants who discontinued study medication due to adverse events. | Posted | Number | participants | 40 weeks |
|
|
|
| Primary | Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score | The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms. | Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline and 52 Weeks |
|
|
|
| Primary | Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score | The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms. | Intent-to-treat are subjects who took at least one dose of double-blind study medication in the extension study and had at least one Y-MRS and MADRS assessment during the extension study. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 52 Weeks |
|
|
|
| 9 |
| 41 |
| 25 |
| 41 |
| EG001 | Placebo | Placebo sublingually BID | 4 | 36 | 18 | 36 |
| EXTRAPYRAMIDAL DISORDER | Nervous system disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| BIPOLAR I DISORDER | Psychiatric disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| DEPRESSIVE SYMPTOM | Psychiatric disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| MANIA | Psychiatric disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| HYPOAESTHESIA ORAL | Gastrointestinal disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| IRRITABILITY | General disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| PYREXIA | General disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| DYSKINESIA | Nervous system disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| PARKINSONISM | Nervous system disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| SEDATION | Nervous system disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| TREMOR | Nervous system disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | 1008:9.1/10, 1009:11 | Systematic Assessment |
|
Institution will provide manuscripts, abstracts, or the full text of any other intended disclosure to the sponsor at least 30 days prior to submission for publication or other disclosure. If any patent action is required to protect intellectual property rights, Institution agrees to delay the disclosure for a period not to exceed and additional 60 days. Institution will, on request, remove any previously undisclosed Confidential Information (other than study results) before disclosure.