Phase 3
Completed N=218
40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)
Source: ClinicalTrials.gov NCT00159783 ↗Enrolled (actual)
218
Serious AEs
7.8%
Results posted
Jul 2010
Primary outcomePrimary: Participants Who Experienced Adverse Event(s) — 23; 68; 85 Participants
Summary
Bipolar disorder is characterized by mood swings that range from 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. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Experienced Adverse Event(s) |
23; 68; 85 | — |
| PRIMARY Number of Participants With Abnormal Physical Examination Findings |
32 | — |
| PRIMARY Number of Participants With Abnormal Electrocardiogram |
0; 2; 0; 0; 1; 0 | — |
| PRIMARY Body Weight |
81.4; 68.1; 72.0; 1.7; 3.5; 6.0 | — |
| PRIMARY Extrapyramidal Symptoms [EPS] |
0.4; 0.1; 0.0; 0.4; 0.2; 0.1 | — |
| PRIMARY Concomitant Medications |
10; 21; 31; 22; 58; 76 | — |
| PRIMARY Abdominal Girth |
91.1; 86.8; 89.4; 3.0; 2.6; 5.0 | — |
| PRIMARY Number of Participants With Markedly Abnormal Vital Sign Changes |
2; 12; 11 | — |
| PRIMARY Number of Participants With Laboratory Values Outside Normal Range |
25; 76; 115; 17; 32; 96 | — |
Eligibility Criteria
Inclusion Criteria
- Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..
Exclusion Criteria
- Patients with unstable medical conditions or clinically significant laboratory
abnormalities.
Data sourced from ClinicalTrials.gov (NCT00159783). 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.