To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00150176

Purpose

Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.

Condition	Intervention	Phase
Schizophrenia	Drug: Asenapine Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Organon:

Primary Outcome Measures:

To determine the efficacy of asenapine compared to placebo with respect to the time to relapse or an impending relapse in schizophrenia subjects who received treatment with asenapine. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

5 dimensions of schizophrenia (positive symptoms, negative symptoms, disorganized thought, hostility/excitement, anxiety/depression); [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Overall clinical impression of severity and improvement; [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Depressive symptoms [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Suicidal thinking [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Cognitive function, as assessed with a computerized cognitive battery [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability [ Time Frame: Up to 1-year ] [ Designated as safety issue: Yes ]

Enrollment:	702
Study Start Date:	April 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental asenapine	Drug: Asenapine 5-10 mg sublingually twice daily for one year
2: Placebo Comparator placebo	Drug: Placebo asenapine-matched placebo sublingually twice 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 primary diagnosis of schizophrenia (DSM IV 295)
History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening
History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening
Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms

Exclusion Criteria:

Have an uncontrolled, unstable clinically significant medical condition
History of suicide attempt or significant violence to others in the past 2 years
A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
Current substance abuse/dependence according to DSM-IV criteria
Concurrent psychiatric disorder other than schizophrenia.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	A7501012
Study First Received:	September 2, 2005
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00150176 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 30, 2009