Schizophrenia MedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
H.Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient or patient?s authorized legal representative must understand the nature of the study and must have given written informed consent. 2. The patient must have completed study 10199 immediately prior to enrolment into the extension study. 3. On the basis of a physical examination, medical history, electrocardiogram, blood biochemistry, haematology tests and a urinalysis carried out at the Termination Visit of study 10199, the patient is, in the investigator?s opinion, otherwise healthy. 4. A female patient of child-bearing potential may be enrolled provided that she: b. has a negative pregnancy test (blood serum beta-HCG) prior to Visit 1 (= Termination Visit of study 10199), and c. is routinely using one of the following medically acceptable methods of birth control: i. oral contraception at a stable dose for at least 3 months prior to entry into the study ii. the first dose of medroxyprogesterone or other i.m. injection administered at least 2 months prior to entry into the study, and has been maintaining the recommended administration schedule. iii. implementation of levonorgestrel system or an inta-uterine device for at least 2 months prior to entry into the study iv. barrier methods (combination of diaphragm and spermicidal or condom and spermicide) prior to and during the trial, and c. is not breast feeding, and d. agrees not to become pregnant during the trial 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients meeting any of the exclusion criteria applying for patients at entry to study 10199, except for exclusion criteria 19 (hospitalisation for the current episode for more than four weeks), 23 (need for continuous treatment with anticholinergic drugs), 24 (exposure to any investigational drug within 60 days prior to study entry), and 26 (prior exposure to bifeprunox), cannot be included in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare the costs and patient-reported outcomes (PRO) of 24-week treatment with either bifeprunox or risperidone in patients with schizophrenia, having completed the pharmacoeconomic study 10224;Secondary Objective: None;Primary end point(s): Sociodemographic data Cost & Patient-Reported Outcome Assessments: Quality of life (S-QoL); Adherance to treatment (DAI) Use of resources (CSRI);Timepoint(s) of evaluation of this end point: PE 1: is the baseline visit of the pharmacoeconomic study. It will take place at the same time as visit 2 of clinical trial 10200, i.e. week 0. PE 2: is the second visit of the pharmacoeconomic study. It will take place at the same time as visit 4 of clinical trial 10200, i.e. end of week 12. PE 3: is the final visit of the pharmacoeconomic study. It will take place at the same time as the termination visit of clinical trial 10200 or at withdrawal, i.e. end of week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium, Germany, Greece, Hong Kong, Malaysia, Netherlands, Philippines, Spain, Sweden, Thailand
Contacts
Public ContactMedical Dircetor
Lundbeck España S.A.
Outcome results
None listed