Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896 AM2)
Status: | Completed |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | September 2010 |
End Date: | March 2013 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
An 8-week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia
This study is designed to evaluate whether asenapine, which is a US FDA-approved acute
treatment for schizophrenia in adults, is also effective in adolescents with schizophrenia.
Participants who qualify for the study will be randomly assigned to receive a fixed dose of
asenapine (either 2.5 mg or 5 mg twice daily [BID]) or placebo for 8 weeks. Throughout the
study, observations will be made on each participant at various times to assess the efficacy
and safety of the study treatment. The primary objective of the trial is to demonstrate
significant superiority of at least one asenapine dose to placebo, as measured by the change
from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at Day 56.
Inclusion Criteria:
- Each participant must have schizophrenia, diagnosed, confirmed and reconfirmed 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.
- 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).
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 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).
We found this trial at
25
sites
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