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6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)

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ClinicalTrials.gov Identifier: NCT00174265
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : July 5, 2010
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

This is an extension study of A7501013 (P05771/NCT00145496) to further test

the efficacy and safety of Asenapine compared with a

marketed agent (olanzapine) in the treatment of patients with

persistent negative symptoms of schizophrenia.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: asenapine Drug: olanzapine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed Protocol A7501013
Study Start Date : July 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: asenapine Drug: asenapine
5-10 mg sublingually twice daily for 26 weeks

Active Comparator: olanzapine Drug: olanzapine
5-20 mg by mouth once daily for 26 weeks
Other Name: Zyprexa




Primary Outcome Measures :
  1. Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score [ Time Frame: Baseline of A7501013 to Day 365 ]
    The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.


Secondary Outcome Measures :
  1. Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score [ Time Frame: Baseline of A7501013 to Day 365 ]
    The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Continue to meet all demographic and procedural

inclusion criteria of the A7501013 trial to enter into

this extension trial.

  • Have demonstrated an acceptable degree of compliance

and completed the A7501013 trial, and would benefit

from continued treatment according to the investigator.

Exclusion Criteria:

  • Have an uncontrolled, unstable clinically significant

medical condition.

  • Have been judged to be medically noncompliant in the

management of their disease.


Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00174265     History of Changes
Other Study ID Numbers: P05772
Aphrodite
A7501014
First Posted: September 15, 2005    Key Record Dates
Results First Posted: July 5, 2010
Last Update Posted: July 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic 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