Clinical trial NCT01190254: Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)
Official title: An 8-week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia, Paranoid
Schizophrenia, Disorganized
Schizophrenia, Undifferentiated
Keywords: Asenapine
adolescents
schizophrenia
phase IIIb
placebo-controlled
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 306
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
timeFrame: Baseline and Day 56
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in PANSS Positive Subscale Score at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in PANSS Negative Subscale Score at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56
timeFrame: Baseline and Day 56
measure: Total PANSS 30% Responders
timeFrame: Baseline up to Day 56
measure: Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study
timeFrame: Baseline up to approximately Day 59
measure: Clinical Global Impression of Improvement (CGI-I) Score at Day 56
timeFrame: Baseline and Day 56
measure: CGI-I Responders
timeFrame: Baseline up to Day 56
measure: Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study
timeFrame: Baseline up to approximately Day 58
measure: Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56
timeFrame: Baseline and Day 56
measure: Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56
timeFrame: Baseline and Day 56
Other outcomes:
Locations:
Study officials:
References:
citation: Findling RL, Landbloom RP, Mackle M, Pallozzi W, Braat S, Hundt C, Wamboldt MZ, Mathews M. Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia. J Child Adolesc Psychopharmacol. 2015 Jun;25(5):384-96. doi: 10.1089/cap.2015.0027.