6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Asenapine 5 mg; Asenapine 10 mg; Placebo
Intervention description: Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks.; Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks.; A matching placebo of asenapine sublingual tablet not containing asenapine
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 532.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the
      efficacy and safety of asenapine compared with placebo in participants with an acute
      exacerbation of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  current diagnosis of schizophrenia of paranoid, disorganized, catatonic, or
             undifferentiated (295.90) subtype

          -  minimum Positive and Negative Syndrome Scale (PANSS) total score of 60 at screening
             and Baseline.

          -  participant had a score of at least 4 in two or more of 5 items in the positive
             subscale of the PANSS at Screening and Baseline.

          -  participant confirmed by the investigator to be experiencing an acute exacerbation of
             schizophrenia as evidenced by ALL of the following:

               -  at the screening test, the duration of the current episode was no more than 2
                  months;

               -  current symptoms represented a dramatic and substantial change compared to the
                  participant's symptomatic state prior to the emergence of the current episode;

               -  participant was in need of changing medication or dosage to treat newly appeared
                  or worsened positive symptoms.

          -  participant had a Clinical Global Impressions-Severity (CGI-S) scale score of at least
             4 (moderately ill) at Baseline;

          -  responded positively to an antipsychotic medication in a prior episode.

          -  discontinued the use of all prohibited concomitant medications, with last dose taken
             no later than the evening prior to the baseline visit (For depot neuroleptic,
             discontinuation must have occurred more than 3 months prior to randomization).

          -  participants must agree to inpatient status for screening period and for up to 42 days
             of dosing and, for out-patient phase, had a caregiver or an identified responsible
             person (e.g., family member, social worker, case worker, or nurse) whom the
             investigator accepts and who has agreed to provide support to the participant to
             ensure compliance with study treatment, out-patient visits, and protocol procedures.

        Exclusion Criteria:

          -  not be treatment-refractory defined by the following criteria: (1) had been treated
             with at least two different atypical anti-psychotic agents at dosages equivalent to or
             greater than 600 mg/day of chlorpromazine (12 mg /day of haloperidol) for more than 4
             weeks, each without clinical response, or (2) has received clozapine for 12 weeks
             immediately preceding the screening.

          -  not have received treatment with 3 or more antipsychotic drugs, or dose-equivalents
             higher than 18 mg/day of haloperidol (equivalent 900 mg/day of chlorpromazine) within
             one month prior to randomization.

          -  not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype;
             schizophreniform disorder, or schizophrenia with course specifiers continuous, single
             episode in partial remission, or single episode in full remission

          -  not have a concurrent psychiatric disorder other than schizophrenia coded on Axis I;
             not have a primary diagnosis other than schizophrenia

          -  not have had a known diagnosis of borderline personality disorder, mental retardation
             or organic brain disorder.

          -  not have a 20% or greater decrease in PANSS total score from screening to baseline

          -  not have an imminent risk of self-harm or harm to others, in the investigator's
             opinion.

          -  not have a substance induced psychotic disorder or a behavioral disturbance thought to
             be due to substance abuse

          -  not be currently under involuntary in-patient confinement.

          -  not been previously treated with asenapine.