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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00159783
First Posted: September 12, 2005
Last Update Posted: February 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

    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 ]
    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 ]
    This is the number of participants with electrocardiogram (ECG) adverse events.

  • Body Weight [ Time Frame: Baseline to Week 40 or endpoint ]
    Weight change from baseline

  • Extrapyramidal Symptoms [EPS] [ Time Frame: 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.


  • Concomitant Medications [ Time Frame: 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.


  • Abdominal Girth [ Time Frame: Baseline to Week 40 or endpoint ]
    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) ]

    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 ]

    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: April 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: April 15, 2010
Results First Posted: July 16, 2010
Last Update Posted: February 25, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Olanzapine
Asenapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents