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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated

Intervention: asenapine 2.5 mg (Drug); asenapine 5.0 mg (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

Official title: An 8-week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56

Secondary outcome:

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56

Change From Baseline in PANSS Positive Subscale Score at Day 56

Change From Baseline in PANSS Negative Subscale Score at Day 56

Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56

Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56

Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56

Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56

Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56

Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56

Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56

Total PANSS 30% Responders

Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study

Clinical Global Impression of Improvement (CGI-I) Score at Day 56

CGI-I Responders

Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study

Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 56

Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56

Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56

Eligibility

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

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).

Locations and Contacts

Additional Information

Starting date: September 2010
Last updated: August 4, 2015

Page last updated: August 23, 2015

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