40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

Phase 3

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: asenapine; Drug: Olanzapine

• Registration Number: NCT00159783
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Results First Submitted: 2010-04-15
• Results First Submitted QC: 2010-06-17
• Results First Posted: 2010-07-16
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asenapine	asenapine	Asenapine 5-10 mg twice daily for 40 weeks
Olanzapine	Olanzapine	Olanzapine 5-20 mg once daily for 40 weeks

Primary Outcome Measures

Name	Time	Method
Body Weight	Baseline to Week 40 or endpoint	Weight change from baseline
Extrapyramidal Symptoms [EPS]	Week 40 or endpoint	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.
Number of Participants With Abnormal Electrocardiogram	Week 40 or endpoint	This is the number of participants with electrocardiogram (ECG) adverse events.
Number of Participants With Laboratory Values Outside Normal Range	Week 40 or endpoint	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
Participants Who Experienced Adverse Event(s)	Up to 40 weeks	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.
Number of Participants With Abnormal Physical Examination Findings	Week 40 or endpoint	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.
Abdominal Girth	Baseline to Week 40 or endpoint	Change in abdominal girth from baseline
Concomitant Medications	Up to 40 weeks	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.
Number of Participants With Markedly Abnormal Vital Sign Changes	Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)	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.