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Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(P05947)

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ClinicalTrials.gov Identifier: NCT00151424
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.

Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Flexible-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine Positive Control in Subjects With an Acute Exacerbation of Schizophrenia
Actual Study Start Date : February 15, 2005
Primary Completion Date : January 6, 2006
Study Completion Date : February 6, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
asenapine 5-10mg BID
Drug: asenapine
Asenapine 5-10mgBID
Placebo Comparator: 2
Placebo
Drug: Placebo
Matched against asenapine and olanzapine
Active Comparator: 3
olanzapine 10-20 mg QD
Drug: Olanzapine
10-20 mg QD


Outcome Measures

Primary Outcome Measures :
  1. Change in total Positive and Negative Syndrome Scale (PANSS) score at endpoint (6-week double-blind or last assessment after baseline) from baseline [ Time Frame: Screen, baseline, days 4, 7, 14, 21, 28, 35, 42 ]
    A 30-item, clinician rated instrument for assessing the symptoms of schizophrenia. Ratings for each item could range from 1 (absent) to 7 (extreme).


Secondary Outcome Measures :
  1. Changes in PANSS subscale and Marder factor score Clinical Global Impression-Severity of Illness (CGI-S) scores [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 ]
    This was not a prespecified key secondary outcome

  2. Clinical Global Impression Improvement (CGI-I) scores [ Time Frame: Days 4,7,14,21,28,35,42 ]
    This was not a prespecified key secondary outcome

  3. Neurocognition and cognitive functioning [ Time Frame: Baseline , day 42 ]
    This was not a prespecified key secondary outcome

  4. Anxiety [ Time Frame: Baseline, day 42 ]
    This was not a prespecified key secondary outcome

  5. Suicidal thinking [ Time Frame: Baseline, day 42 ]
    This was not a prespecified key secondary outcome

  6. Quality of life and patient functionality [ Time Frame: Baseline, day 42 ]
    This was not a prespecified key secondary outcome

  7. Readiness to discharge, at scheduled assessments and endpoint from baseline [ Time Frame: Baseline up to day 14 ]
    This was not a prespecified key secondary outcome

  8. Extrapyramidal symptoms [ Time Frame: Baseline, Days 4,7,14,21,28,35,42 ]
    This was not a prespecified key secondary outcome

  9. Laboratory parameters [ Time Frame: Baseline, Days 14,,28,,42 ]
    This was not a prespecified key secondary outcome

  10. Vital signs [ Time Frame: Baseline, Days ,14,21,28,42 ]
    This was not a prespecified key secondary outcome

  11. Weight [ Time Frame: Baseline, Days 14,,28,,42 ]
    This was not a prespecified key secondary outcome

  12. Electrocardiograms (ECGs) [ Time Frame: Baseline, Days ,14, 28, 42 ]
    This was not a prespecified key secondary outcome

  13. Adverse events (including serious adverse events) [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 7 days after endpoint ]
    This was not a prespecified key secondary outcome

  14. Serious adverse events (SAEs) up to 30 days after endpoint [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 30 days after endpoint ]
    This was not a prespecified key secondary outcome


Eligibility Criteria

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
Criteria

Inclusion Criteria:

  • Currently suffering from an acute exacerbation of schizophrenia.

Exclusion Criteria:

  • Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.
More Information

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00151424     History of Changes
Other Study ID Numbers: P05947
Hera
41022
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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