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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
218
Asenapine, 40 weeks
Olanzapine, 40 weeks
Participants Who Experienced Adverse Event(s)
Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time frame: Up to 40 weeks
Number of Participants With Abnormal Physical Examination Findings
Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm \& rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.
Time frame: Week 40 or endpoint
Number of Participants With Abnormal Electrocardiogram
This is the number of participants with electrocardiogram (ECG) adverse events.
Time frame: Week 40 or endpoint
Body Weight
Weight change from baseline
Time frame: Baseline to Week 40 or endpoint
Extrapyramidal Symptoms [EPS]
EPS was assessed using the (1) involuntary movement scale \[AIMS\], (2) Barnes Akathisia Rating Scale \[BARS\], and (3) Simpson Angus Rating Scale SARS. AIMS score range 0-4; higher scores indicate greater symptom severity. BARS score rang 0-9; higher scores indicate greater severity of akathisia. SARS score range 0-40; higher scores indicate greater degree of Parkinsonism.
Time frame: Week 40 or endpoint
Concomitant Medications
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Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of last dose of double-blind study drug.
Time frame: Up to 40 weeks
Abdominal Girth
Change in abdominal girth from baseline
Time frame: Baseline to Week 40 or endpoint
Number of Participants With Markedly Abnormal Vital Sign Changes
Vital signs measured: sitting blood pressure, heart rate. Definitions: Markedly abnormal decreases: heart rate (HR) - if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) - if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) - if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg. Markedly abnormal increases: HR - if ≥110 bpm and increase from baseline of ≥15 bpm; SBP - if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP - if ≥105 mm Hg and increase from baseline of ≥15 mm Hg.
Time frame: Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)
Number of Participants With Laboratory Values Outside Normal Range
Normal ranges were provided by the central laboratory. Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin Endocrinology/miscellaneous = insulin, prolactin Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils
Time frame: Week 40 or endpoint