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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00212784 |
The primary features of schizophrenia and schizoaffective disorder are characterized by positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder |
Drug: asenapine Drug: olanzapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Double-Blind, Randomized, Active-Controlled, Two-Armed, Multicenter, Efficacy and Safety Assessment (ACTAMESA) of Org 5222 and Olanzapine in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder |
Enrollment: | 1225 |
Study Start Date: | September 2003 |
Study Completion Date: | March 2006 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: asenapine
Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.
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Arm 2: Active Comparator |
Drug: olanzapine
Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily
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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: | 25517, ACTAMESA |
Study First Received: | September 13, 2005 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00212784 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Health and Social Development of the Russian Federation; South Africa: Medicines Control Council; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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 Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Olanzapine Antiemetics Central Nervous System Depressants Antipsychotic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Schizophrenia Serotonin Agents Pathologic Processes Autonomic Agents Mental Disorders Therapeutic Uses Psychotic Disorders Peripheral Nervous System Agents Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |