- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00150176
To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)
February 4, 2022 updated by: Organon and Co
A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
831
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).
Other Names:
Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.
|
Experimental: asenapine
|
Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).
Other Names:
Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
time of first relapse up to Day 182 (double blind phase)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Early Discontinuation for Any Reason
Time Frame: time of discontinuation up to Day 182 (double blind phase)
|
The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).
|
time of discontinuation up to Day 182 (double blind phase)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
September 2, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 8, 2005
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
February 4, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P05770
- A7501012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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