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 investigate the long-term safety and tolerability of flexible doses of bifeprunox, compared to flexible doses of risperidone, over a 6 months treatment period, in patients with schizophrenia, having completed study 10199.;Secondary Objective: To investigate the long-term efficacy of bifeprunox, compared to flexible doses of risperidone, over a 6 months treatment period, in patients with schizophrenia, having completed study 10199.;Primary end point(s): The primary efficacy endpoint will be the change from Baseline of the PANSS total score. Secondary efficacy measurements include the positive symptom sub-scale score of PANSS, the negative symptom sub-scale score of PANSS, the general psychopathology sub-scale of the PANSS, Clinical Global Impression-Severity (CGI-S), CGI-Improvement (CGI-I), Calgary Depression Scale for Schizophrenia (CDSS), relapse rates and responder rates;Timepoint(s) of evaluation of this end point: Visit 1 2 3 4 5 6 Termination Visit1 (TV) Follow-up visit Month 0 1 2 3 4 5 6 or withdrawal 1 week after TV Day 1 31 61 91 121 151 181 188 | — |
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