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Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)

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.
 
ClinicalTrials.gov Identifier: NCT00212836
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date May 2, 2017
Actual Study Start Date  ICMJE April 21, 2005
Actual Primary Completion Date June 15, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
Changes from baseline at 6-months in Negative symptoms of schizophrenia measured by the Negative Symptoms Assessment (NSA) scale [ Time Frame: Change from baseline at 6-months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Improvement in symptoms of schizophrenia (information was omitted due to their commercial sensitivity and will be revealed at a later date)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
  • Change from baseline at 6-months in quality of life measured by the Quality of Life (QLS) scale [ Time Frame: Change from baseline at 6-months ]
  • Positive and negative symptoms and other symptoms of schizophrenia e.g., hostility, excitement, disorganized thoughts and cognition measured by the Positive and Negative Symptom Scale (PANSS) [ Time Frame: Change from baseline at 6-months ]
  • Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Change from baseline at 6-months ]
  • Overall clinical global impression of severity improvement measured by the Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I) [ Time Frame: Change from baseline at 6-months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Information was omitted due to their commercial sensitivity and will be revealed at a later date
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)
Official Title  ICMJE A Multicenter, Double-Blind, Flexible -Dose, 6-Month Trial Comparing the Efficacy Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia
Brief Summary Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, have shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: asenapine
    5-10 mg sublingually twice daily for 26 weeks
  • Drug: olanzapine
    5-20 mg by mouth once daily for 26 weeks
    Other Name: Zyprexa
Study Arms  ICMJE
  • Experimental: Asenapine
    Intervention: Drug: asenapine
  • Active Comparator: Olanzapine
    Intervention: Drug: olanzapine
Publications * Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2017)
481
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
444
Actual Study Completion Date  ICMJE August 2, 2007
Actual Primary Completion Date June 15, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
  • No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
  • Caregiver required.

Exclusion Criteria:

  • Have an uncontrolled, unstable clinically significant medical condition.
  • Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Norway,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00212836
Other Study ID Numbers  ICMJE P05817
Aphrodite;
25543
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP