40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: asenapine Drug: Olanzapine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
- Participants Who Experienced Adverse Event(s) [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]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.
- Number of Participants With Abnormal Electrocardiogram [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]This is the number of participants with electrocardiogram (ECG) adverse events.
- Body Weight [ Time Frame: Baseline to Week 40 or endpoint ] [ Designated as safety issue: Yes ]Weight change from baseline
- Extrapyramidal Symptoms [EPS] [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]
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.
- Concomitant Medications [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: Yes ]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.
- Abdominal Girth [ Time Frame: Baseline to Week 40 or endpoint ] [ Designated as safety issue: Yes ]Change in abdominal girth from baseline
- Number of Participants With Markedly Abnormal Vital Sign Changes [ Time Frame: Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint) ] [ Designated as safety issue: Yes ]
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.
- Number of Participants With Laboratory Values Outside Normal Range [ Time Frame: Week 40 or endpoint ] [ Designated as safety issue: Yes ]
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
| Enrollment: | 218 |
| Study Start Date: | July 2005 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Asenapine
Asenapine 5-10 mg twice daily for 40 weeks
|
Drug: asenapine
Asenapine, 40 weeks
Other Name: Org 5222
|
|
Active Comparator: Olanzapine
Olanzapine 5-20 mg once daily for 40 weeks
|
Drug: Olanzapine
Olanzapine, 40 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00159783 History of Changes |
| Other Study ID Numbers: | A7501007, P05857 |
| Study First Received: | September 8, 2005 |
| Results First Received: | April 15, 2010 |
| Last Updated: | June 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Olanzapine Asenapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 21, 2013