A Trial to Determine Whether Two Differing Strength Tablets (3 x 5 mg Versus 1 x 15 mg) of Sublingually Org 5222 (Asenapine) Are Safe and Equal in Subjects With Schizophrenia or Schizoaffective Disorder (P05937)
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Asenapine 3x5mg followed by 1x15mg; Asenapine 1x15mg followed by 3x5mg
Intervention description: Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days; One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
Intervention MeSH terms: Asenapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A trial to compare if one 15 mg under the tongue tablet is equal to three 5 mg under the
      tongue tablets of Org 5222 (asenapine) in subjects with schizophrenia or schizoaffective
      disorder delivered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  must provide written informed consent after the scope and nature of the investigation
             has been explained to them, but before signing any trial-related activities, including
             screening evaluations;

          -  must be at least 18 and less than 65 years of age;

          -  can be either male or female; females must be either surgically sterile,
             postmenopausal for at least 1 year, or non-pregnant using a method of birth control
             that was acceptable to the investigator;

          -  must be able to speak, read and understand English and be able to respond to questions
             and follow simple instructions;

          -  must be diagnosed at the screening interview according to Diagnostic & Statistical
             Manual of Mental Disorders, 4th edition (DSM-IV), with non-first episode schizophrenia
             or schizoaffective disorder (295.70); if schizophrenia, must be of the following
             types: schizophrenia of the paranoid type (295.30), schizophrenia of the disorganized
             type (295.10), schizophrenia of the catatonic type (295.20), schizophrenia of the
             undifferentiated type (295.90), schizophrenia of the residual type (295.60);

          -  must have discontinued all use of all antipsychotic medication except depot
             neuroleptics at least 3 days prior to baseline. For depot neuroleptics, subjects must
             have completed 1 dosing interval by the baseline interview;

          -  must not have taken any experimental medication for at least 30 days prior to
             baseline;

          -  with hypothyroidism, diabetes, high blood pressure, or chronic respiratory conditions
             can be considered as candidates for enrollment in the trial if their conditions are
             stable, they are receiving standard therapies for the condition, the prescribed dose
             and regimen of medication is stable for at least 3 months, and all appropriate
             clinical and laboratory parameters are within the clinically acceptable limits for the
             condition, and

          -  must be willing to remain in the hospital a minimum of 14 days to approximately 17
             days (minimum of a 3- to a maximum of a 7-day washout period, a minimum of an 8-day
             in-patient period, and a possible 3-day stabilization period, if needed, prior to
             discharge).

        Exclusion Criteria:

          -  they have any untreated or uncompensated clinically significant renal, endocrine,
             hepatic, respiratory, cardiovascular, hematologic, immunologic, or cerebrovascular
             disease, or malignancy;

          -  they are considered obese by the investigator (e.g., greater than 30% above ideal body
             weight);

          -  they have a seizure disorder or are taking anticonvulsants to prevent seizures;

          -  they have any clinically relevant electrocardiogram (ECG) abnormalities at the
             screening visit (Day -2) or at baseline (Day 0);

          -  they have a history of a clinically significant cardiac event that required
             resuscitation;

          -  at the screening visit, on admission to the trial, during the washout period or at
             baseline (Day 0), they have any clinically significant abnormal laboratory, vital
             sign, or physical examination findings which, in the opinion of the investigator,
             would preclude trial participation;

          -  they require concomitant treatment with hypnotics (for sleep induction) other than
             chloral hydrate ≤3000 mg/day, or Ambien (zolpidem tartrate) ≤10 mg qhs, and (for
             agitation) a benzodiazepine such as lorazepam, ≤10 mg/day;

          -  they have a score greater than mild at baseline (score >2) on any item of the Abnormal
             Involuntary Movement Scale (AIMS) assessment at screening and/or require ongoing
             treatment with anticholinergic medication beyond baseline (Day 0);

          -  they have a history of significant drug and/or alcohol abuse (according to DSM-IV
             criteria 305.00) within 30 days before the screening visit;

          -  they have a confirmed positive result on the alcohol/drug screen test for alcohol,
             illegal (excluding marijuana), or non-prescribed drugs at screening or at hospital
             admission;

          -  they had a primary psychiatric diagnosis (according to DSM-IV criteria) other than
             schizophrenia or schizoaffective disorder;

          -  they are actively suicidal at the screening visit, or become so at admission to the
             hospital, during the washout period, or at baseline (Day 0);

          -  they have a Clinical Global Impression (CGI) (Severity of Illness) rating greater than
             moderately ill (score >4) at screening or baseline;

          -  they are non-compliant (>25%) during the washout period (including baseline Day 0);
             or,

          -  they are pregnant, intend to become pregnant during the course of the trial, or are
             currently nursing mothers during the course of the trial.

          -  require concomitant medications that are substrates, inhibitors, or inducers of
             Cytochrome P450 CYP3A4.