None listed
Conditions
Interventions
Group 1 Type of group
Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks.
Group name:Group 3 Type of group
Participants receive placebo asenapine tablets sublingually BID for 8 weeks.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Sex/Gender
All
Age
14 Years to 16 Years
Inclusion criteria
Inclusion criteria: • Each participant must have schizophrenia, diagnosed and confirmed by board-eligible or board certified psychiatrists with at least two years of specialization in pediatric/adolescent psychiatric medicine. • Each participant must be ≥12 years of age and <18 years of age. • Each participant must have a minimum PANSS total score of 80 at Screening and Baseline. • Each participant must have a score of at least 4 (moderate) on two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/ persecution) at Screening and Baseline. • Each participant must have a CGI-S scale score of ≥4 at Screening and Baseline. • Each participant must taper off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers) prior to Baseline. • Each participant must agree not to begin formal, structured psychotherapy during the trial.
Exclusion criteria
Exclusion criteria: • A participant must not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophrenia of catatonic subtype, or schizophrenia with continuous, single episode in partial remission, or single episode in full remission course specifiers. • A participant must not have a primary Axis I diagnosis other than schizophrenia and must not have a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment. • A participant must not have a known or suspected diagnosis of mental retardation or organic brain disorder. • A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR^TM) criteria for substance abuse or dependence (excluding nicotine). • A participant must not have a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse. • A participant 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. Measure:Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 Timepoints:Baseline and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Change from baseline in CGI-S score at Day 56 is the Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participants illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. Measure:Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56 Timepoints:Baseline and Day 56 ; Outcome name:This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. Measure:Change From Baseline in PANSS Positive Subscale Score at Day 56 Timepoints:Baseline and Day 56 ; Outcome name:This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS negative subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 5 | — |
Countries
Bosnial and Herzegovina, Colombia, India, Korea South, Mexico, Netherlands, Palau, Peru, Philippines, Puerto Rico, Romania, Russian Federation, Serbia, South Africa, Ukraine
Contacts
Public ContactElizabeth Beatriz Rospigliosi
I3 LATIN AMERICA PERU S.A.
Outcome results
None listed