Phase 3 N=306 Randomized Quadruple-blind Treatment

Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)

Schizophrenia, Paranoid · Schizophrenia, Disorganized · Schizophrenia, Undifferentiated

Bottom Line

View on ClinicalTrials.gov: NCT01190254 ↗

Enrolled (actual)

306

Serious AEs

2.9%

Results posted

Jun 2014

Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 — -17.8; -23.7; -25.5 score on a scale — p=0.070

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: asenapine 2.5 mg (Drug); asenapine 5.0 mg (Drug); placebo (Drug)
Age: Pediatric · 12+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56	-17.8; -23.7; -25.5	0.070
SECONDARY Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56	-0.8; -1.1; -1.3	0.218
SECONDARY Change From Baseline in PANSS Positive Subscale Score at Day 56	-6.0; -7.9; -9.1	0.067
SECONDARY Change From Baseline in PANSS Negative Subscale Score at Day 56	-3.4; -4.8; -4.9	0.097
SECONDARY Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56	-9.4; -12.7; -14.0	0.062
SECONDARY Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56	-8.5; -10.9; -11.5	0.098
SECONDARY Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56	-6.1; -7.9; -8.9	0.106
SECONDARY Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56	-3.7; -5.2; -5.3	0.083
SECONDARY Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56	-3.4; -4.3; -4.8	0.131
SECONDARY Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56	-2.8; -3.8; -3.8	0.071
SECONDARY Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56	-1.8; -2.4; -2.7	0.263
SECONDARY Total PANSS 30% Responders	36; 48; 51	0.028 sig
SECONDARY Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study	62.0; 64.2; 72.1	0.576
SECONDARY Clinical Global Impression of Improvement (CGI-I) Score at Day 56	3.1; 2.8; 2.5	0.094
SECONDARY CGI-I Responders	28; 36; 41	0.177
SECONDARY Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study	54.7; 47.1; 60.1	0.057
SECONDARY Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 56	10.2; 12.8; 15.0	0.417
SECONDARY Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56	3.1; 3.9; 6.1	0.600
SECONDARY Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56	0.2; 0.3; 0.5	0.407

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 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.

Eligibility 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

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01190254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.