Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00145496

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, has 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

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

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 and Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia.

Further study details as provided by Organon:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Quality of life measured by 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 ]
Safety and tolerability of asenapine will also be assessed throughout the trial systematically through physical examination, clinical laboratory assessments, ECG, vital signs, reports of adverse events and assessment of movement disorders. [ Time Frame: Change from baseline at 6-months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	444
Study Start Date:	December 2004
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (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

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

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	A7501013, Aphrodite;, P05771
Study First Received:	September 1, 2005
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00145496
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Olanzapine

Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009