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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00159783
First received: September 8, 2005
Last updated: April 30, 2014
Last verified: April 2014
  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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00159783     History of Changes
Other Study ID Numbers: P05857, A7501007
Study First Received: September 8, 2005
Results First Received: April 15, 2010
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Olanzapine
Asenapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on August 28, 2014