None listed
Conditions
Interventions
Asenapine Type of group
All enrolled participants receive open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which is increased to 5.0 mg BID on Day 4 (dose can be increased earlier at the investigators discretion). Asenapine dosing is flexible for the remainder of the 26-week open-label drug administration period, and can be adjusted to either 2.5 mg or 5.0 mg BID at the investigators discretion, based on tolerability and/or symptomatology.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Sex/Gender
All
Age
14 Years to 18 Years
Inclusion criteria
Inclusion criteria: • Each participant must be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week base study (P05896 [NCT01190254]) who reach 18 years of age while on P05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met. • Must have completed the 8-week efficacy and safety trial (P05896 [NCT01190254]) and, according to the investigator´s judgment, would benefit from long-term treatment. • Must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896 [NCT01190254]), in the opinion of the investigator.
Exclusion criteria
Exclusion criteria: • A female participant must not be pregnant and must not have the intention to become pregnant during the trial. • A participant must not be at imminent risk of self-harm or harm to others. • A participant must not currently be under involuntary inpatient commitment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was defined as a treatment-emergent AE if it was not present at the extension study baseline, or if it was present at the extension study baseline but worsened in severity compared to baseline during the extension study treatment period. Measure:Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study Timepoints:Up to 30 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Measure:Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE Timepoints:Up to 26 weeks ; Outcome name:Positive and negative syndrome scale (PANSS): A 30-item instrument qualified by a clinical physician to assess the symptoms of schizophrenia.® The structured clinical interview for PANSS will be used. Measure:Change with respect to the baseline value (s) in the total PANSS score. Timepoints:During the study ; Outcome name:Failure to maintain the effect will be described in those subjects of the complete analysis set (FAS), who are considered subjects that responded to the treatment with a 30% decrease in the total PANSS score at the end of the P05896 Study. Measure:Time elapsed until effect maintenance fails Timepoints:During the study ; Outcome name:Positive and negative syndrome scale (PANSS): A 30-item instrument qualified by a clinical physician to assess the symptoms of schizophrenia.® The structured clinical interview for PANSS will be used. Measure:Proportion of subjects who submitted remission according to the PANSS. Timepoints:During the study ; Outcome name:Positive and negative syndrome scale (PANSS): A 30-item instrument qualified by a clinical physician to assess the symptoms of schizophrenia.® The structured clinical interview for PANSS will be used. Measure:Proportion of subjects who presented sustained remission according to the PANSS. Timepoints:During the study | — |
Contacts
Public ContactElizabeth Beatriz Rospigliosi
I3 LATIN AMERICA PERU S.A.
Outcome results
None listed