Clinical trial NCT00150176: To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)
Official title: A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 831
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 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/impending relapse (hereafter referred to as '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.


Eligibility criteria: Key Inclusion Criteria:

* Have a primary diagnosis of schizophrenia
* 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

Key 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
* Concurrent psychiatric disorder other than schizophrenia.

Primary outcomes:
measure: Time to Relapse or an Impending Relapse
timeFrame: time of first relapse up to Day 182 (double blind phase)
Secondary outcomes:
measure: Time to Early Discontinuation for Any Reason
timeFrame: time of discontinuation up to Day 182 (double blind phase)
Other outcomes:
Locations:
Study officials:
References:
citation: Kane JM, Mackle M, Snow-Adami L, Zhao J, Szegedi A, Panagides J. A randomized placebo-controlled trial of asenapine for the prevention of relapse of schizophrenia after long-term treatment. J Clin Psychiatry. 2011 Mar;72(3):349-55. doi: 10.4088/JCP.10m06306. Epub 2011 Feb 22.