A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Asenapine; Placebo Asenapine; Olanzapine; Placebo Olanzapine
Intervention description: 2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually; Fast dissolving placebo asenapine tablets (to match 2.5 mg and 5 mg active asenapine tablets) administered sublingually; 5 and 10 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding; Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally
Intervention MeSH terms: Olanzapine; Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually
      twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms)
      as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15
      mg orally once daily (QD) was used as an active control. The primary hypothesis is that at
      least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms
      as measured by the change from Baseline in the PANSS total score at Day 42. The first key
      secondary hypothesis is that at least one of the asenapine doses is superior to placebo in
      improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global
      Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is
      that at least one of the asenapine doses is superior to placebo in improving schizophrenia
      symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS
      Total Score) at Day 42.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current diagnosis of schizophrenia of paranoid, disorganized, or undifferentiated
             subtype

          -  Minimum PANSS total score of 70 at Screening and Baseline

          -  Score of at least 4 (moderate) in two or more of the five items in the positive
             subscale of the PANSS

          -  Confirmed to be experiencing an acute exacerbation of schizophrenia

          -  CGI-S scale score of at least 4 (moderately ill) at Baseline

          -  Has responded positively to an antipsychotic medication other than clozapine
             (Clozaril®) in a prior episode

        Exclusion Criteria:

          -  Body mass index (BMI) <18.5 or >40.0 kg/m^2

          -  Laboratory and/or clinical evidence of clinically significant hepatic conditions

          -  Known history of, or undergoing treatment for, narrow angle glaucoma

          -  Diagnosed with epilepsy or has had any seizure disorder beyond childhood febrile
             seizures

          -  Known serological evidence of human immunodeficiency virus (HIV) antibody

          -  History of neuroleptic malignant syndrome or tardive dyskinesias

          -  Past or current diagnosis of schizoaffective disorder, schizophrenia of residual
             subtype, schizophrenia of catatonic subtype, current diagnosis of schizophrenia with
             course specifiers continuous, single episode in partial remission, or single episode
             in full remission, or borderline personality disorder