6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the First 6- Month Trial (25544)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00265343

Purpose

Asenapine is an investigational drug that may help patients with schizophrenia. This is an extension study to further test the efficacy and safety of asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.

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, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed the Protocol 25543

Further study details as provided by Organon:

Primary Outcome Measures:

Long-term improvement in negative symptoms of schizophrenia measured by the Negative Symptom Assessment (NSA) scale [ Time Frame: At 1-year ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: At 1-year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Sustained improvement in quality of life measured by QLS scale [ Time Frame: Sustained improvement from baseline to 1-year ] [ Designated as safety issue: No ]
Positive and negative symptoms and other symptoms of schizophrenia such as hostility, excitement, disorganized thoughts and cognition measured by the PANSS [ Time Frame: Sustained improvement from baseline to 1-year ] [ Designated as safety issue: No ]
Depressive symptoms measured by the CDSS [ Time Frame: Sustained improvement from baseline to 1-year ] [ Designated as safety issue: No ]
Overall clinical global impression of severity and improvement measured by the CGI-S and CGI-I [ Time Frame: Sustained improvement from baseline to 1-year ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	December 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental asenapine	Drug: asenapine 5-10 mg sublingually twice daily for 26 weeks
2: Active Comparator olanzapine	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:

Continue to meet all demographic and procedural inclusion criteria of the first 6-month trial to enter into this extension trial.
Have demonstrated an acceptable degree of compliance and completed the 25543 trial, and would benefit from continued treatment according to the investigator.

Exclusion Criteria:

Have an uncontrolled, unstable clinically significant medical condition.
Have been judged to be medically noncompliant in the management of their disease.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	25544, Aphrodite
Study First Received:	December 12, 2005
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00265343
Health Authority:	Finland: National Agency for Medicines

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