Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)
Condition: Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated
MeSH terms: Schizophrenia; Schizophrenia, Paranoid; Schizophrenia, Disorganized
Intervention: asenapine 2.5 mg; asenapine 5.0 mg; placebo
Intervention description: asenapine 2.5 mg tablets for sublingual administration; asenapine 5.0 mg tablets for sublingual administration; asenapine-matched placebo tablets for sublingual administration
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 306.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Asenapine; adolescents; schizophrenia; phase IIIb; placebo-controlled

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).