Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Schizophrenia for patients who completed protocol P05688(P05688 AM1)
- Conditions
- SchizophreniaMedDRA version: 17.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2010-018408-96-BG
- Lead Sponsor
- Schering-Plough Research Institute, a Division of Schering
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
Each subject must be at least 18 years of age and of legal minimum age for signing the consent form.
• Each subject must have completed the short-term trial P05688, and be judged by the investigator likely to benefit from continued treatment.
• Each subject must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05688 in the opinion of the investigator.
• Each subject must be able to adhere to dose and visit schedules and have a caregiver or an identified responsible person who is considered reliable by the investigator and who has agreed to provide support to the subject to ensure compliance with trial treatment, outpatient visits, and protocol procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
A subject must not have had any occurrence(s) of an adverse event or other clinically significant finding(s) in the short-term trial P05688 that would prohibit the subject’s continuation into this long-term extension trial.
• A subject must not have a CGI-S score of =6 (severely psychotic) at Baseline.
• A subject must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05688, including a primary Axis I diagnosis other than schizophrenia or a comorbid Axis I diagnosis that is primarily responsible for current symptoms
and functional impairment.
• A subject must not currently (within the time period between the past 6 months prior to the short-term trial P05688 and Baseline for the current trial) meet the DSM-IV-TR(TM) criteria for substance abuse or dependence (excluding nicotine).
• A subject must not be at imminent risk of self-harm or harm to others, in the investigator’s opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this trial is to evaluate the long-term safety of 2.5 and 5 mg BID asenapine in schizophrenia subjects.;Secondary Objective: Evaluate weight change associated with asenapine compared with olanzapine.;Timepoint(s) of evaluation of this end point: The key safety endpoint is the change from short-term trial Baseline (P05688) to Day 182 in weight.;Primary end point(s): There is no primary efficacy endpoint. All efficacy endpoints are considered secondary. The primary objective in the current trial is assessing the long-term safety of asenapine.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The efficacy endpoints will be the PANSS total and subscale scores (positive, negative, general psychopathology), PANSS<br>responders, PANSS Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression), scores on the CGI-S and CGI-I, CGI-responders and the change from baseline scores.<br>For the secondary efficacy analyses, the change from short-term trial Baseline (P05688) and the change from this extension trial Baseline (P05689) will be analyzed.<br>;Timepoint(s) of evaluation of this end point: Baseline to day 182.