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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00156091 |
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.
The clinical development of asenapine, as described in the 2007 IDB appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics. Its fast dissolving formulation may further add to treatment compliance. While various titration schedules have been used in previous studies, dose increases at 5 mg BID up to 10 mg BID have been well tolerated.
Therefore, further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual clinical practice in a long-term 52-week extension trial.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Olanzapine Drug: Asenapine Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Historical Control, Parallel Assignment, Safety Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Flexible-Dose, Long-Term Extension Trial of the Safety and Maintenance of Effect of Asenapine Using Olanzapine Positive Control in Subjects Who Complete Protocols 041021 or 041022. |
Enrollment: | 260 |
Study Start Date: | April 2005 |
Study Completion Date: | June 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Olanzapine 20 mg QD
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Drug: Olanzapine
5- 20 mg QD
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2: Experimental
Asenapine 5 or 10 mg BID
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Drug: Asenapine
5 or 10 mg BID
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Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041021 or 041022 asenapine trials, were randomized (double-blind) Into the long-term 041512 asenapine extension trial and received asenapine 5 mg BID for Week 1. After Week 1, subjects received asenapine (either 5 mg BID or 10 mg BID) for the remainder of the 52 week trial.
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Other: Placebo |
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: | 41512, Hera |
Study First Received: | September 8, 2005 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00156091 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 |