6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)

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. Identifier: NCT00265343
Recruitment Status : Completed
First Posted : December 14, 2005
Results First Posted : February 23, 2010
Last Update Posted : March 10, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

This is an extension study 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 : 306 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 the Protocol 25543 (NCT 00212836; P05817)
Study Start Date : December 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: asenapine
5-10 mg sublingually twice daily for 26 weeks
Active Comparator: 2
Drug: olanzapine
5-20 mg by mouth once daily for 26 weeks

Primary Outcome Measures :
  1. Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale [ Time Frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) ]
    Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst].

Secondary Outcome Measures :
  1. Change in Quality of Life Measured by Quality of Life Scale (QLS) [ Time Frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) ]
    Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best].

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Continue to meet all demographic and procedural

inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into

this extension trial.

  • Have demonstrated an acceptable

degree of compliance and completed the 25543

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. Identifier: NCT00265343     History of Changes
Other Study ID Numbers: P05777
First Posted: December 14, 2005    Key Record Dates
Results First Posted: February 23, 2010
Last Update Posted: March 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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