A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 831
- Primary Endpoint
- Time to Relapse or an Impending Relapse
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Arms & Interventions
asenapine
Intervention: Asenapine - Double Blind (Drug)
placebo
Intervention: Placebo - Double Blind (Drug)
asenapine
Intervention: Asenapine - Open Label (Drug)
placebo
Intervention: Asenapine - Open Label (Drug)
Outcomes
Primary Outcomes
Time to Relapse or an Impending Relapse
Time Frame: time of first relapse up to Day 182 (double blind phase)
A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.
Secondary Outcomes
- Time to Early Discontinuation for Any Reason(time of discontinuation up to Day 182 (double blind phase))