Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(COMPLETED)(P05846) - Full Text View

Purpose

The primary features of schizophrenia and schizoaffective disorder are 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 maintaining productive employment.

Asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	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:	Long-Term Efficacy and Safety Evaluation of Asenapine (10-20 mg/Day) in With Schizophrenia or Schizoaffective Disorder, in a Multicenter Trial Using (10-20 mg/Day) as a Control

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:

Change in total PANSS score at endpoint [ Time Frame: Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in PANSS subscale scores and Marder factor scores [ Time Frame: Every 24 weeks after baseline ] [ Designated as safety issue: No ]
Changes in CGI-S [ Time Frame: Every 12 weeks after baseline ] [ Designated as safety issue: No ]
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN) [ Time Frame: Every 48 weeks after baseline ] [ Designated as safety issue: No ]
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia) [ Time Frame: Every 24 weeks after baseline ] [ Designated as safety issue: No ]
Resource utilization (as measured by frequency and length of hospital stay) [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
Safety and tolerability: EPS (AIMS, BARS, SARS) [ Time Frame: Every 24 weeks after baseline ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: Continuously and up to 7 days after endpoint ] [ Designated as safety issue: Yes ]
Pregnancy Test [ Time Frame: At endpoint ] [ Designated as safety issue: No ]
Blood Tests [ Time Frame: Every 12 weeks after baseline ] [ Designated as safety issue: No ]
Weight and vital signs [ Time Frame: Every 4 weeks after baseline ] [ Designated as safety issue: No ]
ECGs [ Time Frame: Every 24 weeks after baseline ] [ Designated as safety issue: No ]

Enrollment:	440
Study Start Date:	September 2004
Study Completion Date:	October 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	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. Other Names: Org 5222 SCH 900274
Active Comparator: Arm 2	Drug: olanzapine Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo. Other Name: Zyprexa

Eligibility

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

Criteria

Inclusion Criteria:

Subject with schizophrenia or schizoaffective disorder. Must have completed 12 months treatment under protocol 25517. Subject must sign a written informed consent.

Exclusion Criteria:

Have an uncontrolled, unstable, clinically significant medical condition.

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:	NCT00212771 History of Changes
Other Study ID Numbers:	25520, P05846
Study First Received:	September 13, 2005
Last Updated:	October 2, 2009
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation South Africa: Medicines Control Council Slovenia: Agency for Medicinal Products - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Psychotic Disorders
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 19, 2013

Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(COMPLETED)(P05846) (ACTAMESA)