Phase 3
Completed N=326
12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)
Source: ClinicalTrials.gov NCT00145470 ↗Enrolled (actual)
326
Serious AEs
13.9%
Results posted
Sep 2019
Primary outcomePrimary: Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21 — 28.2; 27.9; -7.9; -10.3 Score on a Scale — p=0.0257
◆ Published Evidence
Established
89citations · ~6 / year
Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension.
Summary
This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.
Linked Publications
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Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21 |
28.2; 27.9; -7.9; -10.3 | 0.0257 sig |
| SECONDARY Number of Participants Experiencing an Adverse Event (AE) |
114; 116 | — |
| SECONDARY Number of Participants Discontinuing Study Treatment Due to an AE |
18; 25 | — |
| SECONDARY Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 42 |
28.2; 27.9; -8.7; -11.4 | 0.0210 sig |
| SECONDARY Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 84 |
28.2; 27.9; -9.3; -12.7 | 0.0073 sig |
| SECONDARY Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Responder Status |
10; 13; 25; 22; 34; 46 | 0.3928 |
| SECONDARY Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Remitter Status |
8; 11; 21; 19; 32; 42 | 0.3709 |
| SECONDARY Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Mania Score at Day 21 |
4.5; 4.5; -0.8; -1.1 | 0.0046 sig |
| SECONDARY Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Mania Score at Day 84 |
4.5; 4.5; -1.0; -1.5 | 0.0006 sig |
| SECONDARY Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Depression Score at Day 21 |
2.3; 2.3; -0.1; -0.2 | 0.3497 |
| SECONDARY Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Depression Score at Day 84 |
2.3; 2.3; -0.1; -0.1 | 0.7753 |
| SECONDARY Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Overall Bipolar Illness Score at Day 21 |
4.6; 4.6; -0.7; -1.0 | 0.0073 sig |
| SECONDARY Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Overall Bipolar Illness Score at Day 84 |
4.6; 4.6; -0.8; -1.2 | 0.0102 sig |
| SECONDARY Least Squares Mean Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score at Day 21 |
11.4; 11.3; -2.2; -2.9 | 0.3684 |
| SECONDARY Least Squares Mean Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score at Day 84 |
11.4; 11.3; -1.7; -1.6 | 0.9370 |
| SECONDARY Least Squares Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Day 21 |
67.1; 65.1; -5.4; -7.2 | 0.2492 |
| SECONDARY Least Squares Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Day 84 |
67.1; 65.1; -6.0; -7.4 | 0.4683 |
| SECONDARY Least Squares Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Day 21 |
9.3; 8.8; -2.1; -2.4 | 0.5683 |
| SECONDARY Least Squares Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Day 84 |
9.3; 8.8; -2.1; -2.1 | 0.9693 |
| SECONDARY Least Squares Mean Change From Baseline in InterSePT Scale for Suicidal Thinking - Modified Version (ISST-Modified) Score at Day 21 |
0.6; 0.4; -0.0; 0.0 | 0.6136 |
| SECONDARY Least Squares Mean Change From Baseline in InterSePT Scale for Suicidal Thinking - Modified Version (ISST-Modified) Score at Day 84 |
0.6; 0.4; -0.0; 0.3 | 0.1586 |
| SECONDARY Mean Change From Baseline (CFB) at Day 21 in Neurocognitive Function as Determined by Central Nervous System Vital Signs (CNS-VS) Test Battery |
43.6; 44.6; 38.0; 38.2; 34.3; 39.5 | 0.0550 |
| SECONDARY Mean Change From Baseline (CFB) at Day 84 in Neurocognitive Function as Determined by Central Nervous System Vital Signs (CNS-VS) Test Battery |
43.6; 44.6; 38.0; 38.2; 34.3; 39.5 | 0.6914 |
| SECONDARY Percentage of Participants Determined to be Ready to Discharge at Day 84 (Kaplan-Meier Estimation) |
74.1; 89.7 | 0.0613 |
| SECONDARY Least Squares Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), General Activities Subscale Score at Day 21 |
61.0; 61.3; 3.9; 4.6 | 0.7493 |
| SECONDARY Least Squares Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), General Activities Subscale Score at Day 84 |
61.0; 61.3; -3.7; -1.1 | 0.4884 |
| SECONDARY Least Squares Mean Change From Baseline at Day 21 in Quality of Life as Determined by Short Form-36 Version 2 (SF-36v2) |
50.49; 51.64; -0.72; -2.47; 40.83; 39.03 | 0.1280 |
| SECONDARY Least Squares Mean Change From Baseline at Day 84 in Quality of Life as Determined by Short Form-36 Version 2 (SF-36v2) |
50.49; 51.64; 1.37; -0.95; 40.83; 39.03 | 0.1331 |
Eligibility Criteria
Inclusion Criteria
- Have bipolar I disorder, current episode manic or mixed
- Treated with lithium or valproic acid
Exclusion Criteria
- Have an unstable medical condition
- Clinically significant laboratory abnormality.
- Have a primary diagnosis other than bipolar I disorder.
Data sourced from ClinicalTrials.gov (NCT00145470) and the linked publication. 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. Informational only — not medical advice.