Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817) - Full Text View

Purpose

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Asenapine Olanzapine Olanzapine pamoate

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Changes from baseline at 6-months in Negative symptoms of schizophrenia measured by the Negative Symptoms Assessment (NSA) scale [ Time Frame: Change from baseline at 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline at 6-months in quality of life measured by the Quality of Life (QLS) scale [ Time Frame: Change from baseline at 6-months ] [ Designated as safety issue: No ]
Positive and negative symptoms and other symptoms of schizophrenia e.g., hostility, excitement, disorganized thoughts and cognition measured by the Positive and Negative Symptom Scale (PANSS) [ Time Frame: Change from baseline at 6-months ] [ Designated as safety issue: No ]
Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Change from baseline at 6-months ] [ Designated as safety issue: No ]
Overall clinical global impression of severity improvement measured by the Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I) [ Time Frame: Change from baseline at 6-months ] [ Designated as safety issue: No ]

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
Experimental: Asenapine	Drug: asenapine 5-10 mg sublingually twice daily for 26 weeks
Active Comparator: Olanzapine	Drug: olanzapine 5-20 mg by mouth once daily for 26 weeks Other Name: Zyprexa

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
Caregiver required.

Exclusion Criteria:

Have an uncontrolled, unstable clinically significant medical condition.
Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00212836 History of Changes
Other Study ID Numbers:	25543, Aphrodite;, P05817
Study First Received:	September 13, 2005
Last Updated:	October 2, 2009
Health Authority:	Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2013