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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00156117 |
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 | Intervention | Phase |
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Schizophrenia |
Drug: asenapine Drug: Placebo Drug: olanzapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 417 |
Study Start Date: | May 2005 |
Study Completion Date: | May 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
asenapine 5 mg BID and 10 mg BID
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Drug: asenapine
5 mg BID or 10mg BID
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2: Placebo Comparator
Placebo against olanzapine and asenapine
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Drug: Placebo
Placebo
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3: Active Comparator
olanzapine 15 mgQD
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Drug: olanzapine
olanzapine 15 mg QD
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | 41021, Hera |
Study First Received: | September 8, 2005 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00156117 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Tranquilizing Agents Olanzapine Psychotropic Drugs Central Nervous System Depressants Antiemetics Antipsychotic Agents |
Serotonin Uptake Inhibitors Serotonin Schizophrenia Mental Disorders Psychotic Disorders Peripheral Nervous System Agents Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Olanzapine Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Schizophrenia Serotonin Agents Autonomic Agents Mental Disorders Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |