To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Asenapine - Open Label (Drug); Placebo - Double Blind (Drug); Asenapine - Double Blind (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Time to Relapse or an Impending Relapse
Secondary outcome: Time to Early Discontinuation for Any Reason
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: April 2005
Last updated: January 14, 2015
|