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Sponsored by: |
Organon |
---|---|
Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00212836 |
Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, have shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
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 Multicenter, Double-Blind, Flexible -Dose, 6-Month Trial Comparing the Efficacy Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia |
Estimated Enrollment: | 444 |
Study Start Date: | May 2005 |
Study Completion Date: | June 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Asenapine: Experimental |
Drug: asenapine
5-10 mg sublingually twice daily for 26 weeks
|
Olanzapine: Active Comparator |
Drug: olanzapine
5-20 mg by mouth once daily for 26 weeks
|
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: | 25543, Aphrodite |
Study First Received: | September 13, 2005 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00212836 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Norway: Norwegian Medicines Agency; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; South Africa: Medicines Control Council; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Australia: Department of Health and Ageing Therapeutic Goods 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 |