Schizophrenia
Conditions
Interventions
Product Name: Asenapine maleate
Product Code: Org 5222
Pharmaceutical Form: Tablet
INN or Proposed INN: Asenapine maleate
CAS Number: 85650-56-2
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Pfizer Luxembourg SARL Latvia Branch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. at least 18 years of age, 2. signed informed consent, 3. a male, or a woman who is not of child-bearing potential (and breastfeeding), 4. fluent in the language of an investigator and study staff, 5. having a caregiver or an identified responsible person, 6. having access to appropriate supervision during the randomized treatment period, 7. primary diagnosis of schizophreania 8. documented history of at least 1 year episode of acute schizophrenia 9. antipsychotic treatment required for at least 2 years etc. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of asenapine compared to placebo with respect to the time to an impending relapse in schizophrenia subjects who received treatment with asenapine for 26 weeks.;Secondary Objective: To compare asenapine and placebo treatment for up to 1 year in schizophrenia subjects previously treated with asenapine for 26 weeks with respect to: 1. the 5 dimensions of schizophrenia 2. overall clinical impression of severity and imrpovement 3. depressive symptoms 4. suidical thinking 5. cognitive function, as assessed with a computerised cognitive battery 6. safety and tolerability;Primary end point(s): | — |
Countries
Latvia
Outcome results
None listed