Status:
COMPLETED
Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)
Lead Sponsor:
Organon and Co
Conditions:
Schizophrenia, Paranoid
Schizophrenia, Disorganized
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also effective in ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT01190254
Start Date
September 28 2010
End Date
April 1 2013
Last Update
May 21 2024
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