Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)

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: NCT00156117
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 417 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, Fixed-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 : May 12, 2005
Actual Primary Completion Date : April 28, 2006
Actual Study Completion Date : May 30, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
asenapine 5 mg BID and 10 mg BID
Drug: asenapine
5 mg BID or 10mg BID
Placebo Comparator: 2
Placebo against olanzapine and asenapine
Drug: Placebo
Active Comparator: 3
olanzapine 15 mgQD
Drug: olanzapine
olanzapine 15 mg QD

Primary Outcome Measures :
  1. Change in total 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 ]

Secondary Outcome Measures :
  1. Changes in PANSS subscale and Marder factor scores; CGI-S scores [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 ]
  2. CGI-I scores [ Time Frame: Days 4,7,14,21,28,35,42 ]
  3. Neurocognition and cognitive functioning [ Time Frame: Baseline , day 42 ]
  4. Anxiety [ Time Frame: Baseline, day 42 ]
  5. Suicidal thinking [ Time Frame: Baseline, day 42 ]
  6. Quality of life and patient functionality [ Time Frame: Baseline, day 42 ]
  7. Readiness to discharge, at scheduled assessments and endpoint from baseline [ Time Frame: Baseline up to day 14 ]
  8. Extrapyramidal symptoms [ Time Frame: Baseline, Days 4,7,14,21,28,35,42 ]
  9. Laboratory parameters [ Time Frame: Baseline, Days 14,,28,,42 ]
  10. Vital signs [ Time Frame: Baseline, Days ,14,21,28,42 ]
  11. Weight [ Time Frame: Baseline, Days 14,,28,,42 ]
  12. ECGs [ Time Frame: Baseline, Days ,14,,28,,42 ]
  13. Adverse events (including serious adverse events) [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 7 days after endpoint ]
  14. SAEs up to 30 days after endpoint [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 30 days after endpoint ]

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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:

  • Currently suffering from an acute exacerbation of schizophrenia. Caregiver required.

Exclusion Criteria:

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

Study Data/Documents: CSR Synopsis  This link exits the site

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00156117     History of Changes
Other Study ID Numbers: P05933
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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