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

Bipolar Disorder Clinical Trial

Official title:

A Double-Blind, 40-Week Continuation Study Evaluating the Safety of Asenapine and Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501007 (Secondary Title: ARES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159783
• Other study ID #: P05857
• Secondary ID: A7501007
• Status: Completed
• Phase: Phase 3
• Start date: July 2005
• Est. completion date: April 2007

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• asenapine
Asenapine, 40 weeks
• Olanzapine
Olanzapine, 40 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Pfizer

References & Publications (1)

McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord. 2010 Nov;126(3):358-65. doi: 10.1016/j.jad.2010.04.005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 40 weeks
Primary	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.	Week 40 or endpoint
Primary	Number of Participants With Abnormal Electrocardiogram	This is the number of participants with electrocardiogram (ECG) adverse events.	Week 40 or endpoint
Primary	Body Weight	Weight change from baseline	Baseline to Week 40 or endpoint
Primary	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.	Week 40 or endpoint
Primary	Concomitant Medications	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.	Up to 40 weeks
Primary	Abdominal Girth	Change in abdominal girth from baseline	Baseline to Week 40 or endpoint
Primary	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.	Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)
Primary	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	Week 40 or endpoint