Phase 3
Completed N=77
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
Source: ClinicalTrials.gov NCT00145509 ↗Enrolled (actual)
77
Serious AEs
16.9%
Results posted
Apr 2010
Primary outcomePrimary: Number of Participants Who Experienced an Adverse Event — 32; 25 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event |
32; 25 | — |
| PRIMARY Number of Participants Who Discontinued Because of an Adverse Event |
10; 3 | — |
| PRIMARY Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score |
-17.2; -19.7 | — |
| PRIMARY Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score |
-3.3; -3.9 | — |
Eligibility Criteria
Inclusion Criteria
- Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial
Exclusion Criteria
- Have an unstable medical condition or clinically significant laboratory abnormality.
- Have a primary diagnosis other than bipolar I disorder.
Data sourced from ClinicalTrials.gov (NCT00145509). 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.