Phase 3
N=367
Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)
Bipolar 1 Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00764478 ↗Enrolled (actual)
367
Serious AEs
1.6%
Results posted
Apr 2015
Primary outcome: Primary: Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21 — -14.4; -14.9; -10.9 Score on a scale — p=0.0136
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Asenapine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21 |
-14.4; -14.9; -10.9 | 0.0136 sig |
| SECONDARY Change From Baseline in Clinical Global Impression - Bipolar Mania - Severity of Illness (CGI-BP-S) Overall Score at Day 21 |
-1.6; -1.7; -1.1 | 0.0100 sig |
| SECONDARY Percentage of Participants Who Are Y-MRS Responders at Day 21 |
45.0; 46.9; 39.7 | 0.5352 |
| SECONDARY Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14 |
-5.6; -5.8; -2.9; -8.6; -8.6; -4.9 | 0.0007 sig |
| SECONDARY Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14 |
12.0; 14.4; 8.9; 21.7; 23.0; 8.7 | 0.2922 |
| SECONDARY Percentage of Participants Who Are Y-MRS Remitters at Day 21 |
34.2; 38.1; 30.2 | 0.2912 |
| SECONDARY Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21 |
8.5; 11.7; 5.7; 17.3; 15.1; 10.2 | — |
| SECONDARY Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score |
-4.3; -4.2; -2.3; -4.6; -5.1; -2.5 | 0.0019 sig |
| SECONDARY Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14 |
-0.5; -0.4; -0.2; -0.8; -0.7; -0.4 | <0.0001 sig |
| SECONDARY Change From Baseline in CGI-BP-S Mania Score |
-0.4; -0.4; -0.1; -0.7; -0.7; -0.3 | 0.0005 sig |
| SECONDARY Change From Baseline in CGI-BP-S Depression Score |
-0.2; -0.2; -0.2; -0.3; -0.3; -0.3 | 0.9708 |
| SECONDARY Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score |
50.8; 45.9; 37.4; 64.2; 64.6; 55.6 | 0.0147 sig |
| SECONDARY Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score |
49.2; 45.9; 37.4; 64.2; 66.4; 55.6 | 0.0377 sig |
| SECONDARY Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score |
21.2; 28.2; 11.2; 26.7; 32.1; 19.3 | 0.0104 sig |
| SECONDARY Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score |
-6.9; -6.9; -3.9; -7.5; -8.4; -5.2 | 0.0056 sig |
| SECONDARY Change From Baseline in PANSS Negative Subscale Score |
-0.5; -0.8; -0.5; -0.8; -0.7; -0.8 | 0.9808 |
| SECONDARY Change From Baseline in PANSS Positive Subscale Score |
-2.4; -2.8; -1.4; -2.3; -3.2; -2.1 | 0.0120 sig |
| SECONDARY Change From Baseline in PANSS General Psychopathology Subscale Score |
-4.0; -3.3; -2.1; -4.5; -4.6; -2.4 | 0.0033 sig |
| SECONDARY Change From Baseline in PANSS Marder Factor Positive Symptom Score |
-1.9; -1.9; -1.3; -1.6; -2.5; -1.6 | 0.1883 |
| SECONDARY Change From Baseline in PANSS Marder Factor Negative Symptom Score |
-0.5; -0.8; -0.5; -0.6; -0.5; -0.7 | 0.7746 |
| SECONDARY Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score |
-1.1; -1.3; -0.7; -1.5; -1.8; -1.2 | 0.2191 |
| SECONDARY Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score |
-1.7; -1.7; -0.9; -1.8; -2.0; -1.2 | 0.0101 sig |
| SECONDARY Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score |
-1.7; -1.3; -0.7; -2.0; -1.7; -0.7 | 0.0019 sig |
Summary
This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily [BID]) or placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. The primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating Scale [YMRS]) at Day 21 of the trial.
Eligibility Criteria
Inclusion Criteria
- Each participant must be at least 18 years of age
- Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception
- Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
- Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
- Each participant must have discontinued the use of all prohibited psychotropic medications
Exclusion Criteria
- A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
- A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
- A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).
Data sourced from ClinicalTrials.gov (NCT00764478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.