An open-label safety study of bifeprunox investigating flexible doses of 20, 30, or 40mg/day in patients with schizophrenia who have completed studies 10206 or 10265 - ND
- Conditions
- male and female patients with schizophreniaMedDRA version: 6.1Level: PTClassification code 10039626
- Registration Number
- EUCTR2005-000497-50-IT
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 207
1. The patient and/or patient s authorised legal representative must understand the nature of the study and must have given written informed consent. 2. The patient must have completed studies 10206 or 10265 prior to enrolment into study 11051. 3. The patient must be in need of treatment with bifeprunox that is, the patient cannot be switched to another compound approved for the treatment of schizophrenia . 4. On the basis of a physical and neurological examination, medical/psychiatric/ neurological history, electrocardiogram, blood biochemistry, haematology tests and a urinalysis carried out at the Termination Visit of studies 10206 or 10265 or at Baseline Visit, the patient is, in the investigator s opinion, otherwise healthy. 5. A female patient of childbearing potential may be enrolled provided that she a. has a negative pregnancy test blood serum 61538;-human chorionic gonadotropin HCG at Visit 1 Baseline Visit and/or Termination Visit of studies 10206 or 10265 , and b. 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 Baseline ii. the first dose of medroxyprogesterone or other i.m. injection administered at least 2 months prior to Baseline, 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 Baseline iv. barrier methods combination of diaphragm and spermicidal or condom and spermicide prior to and during the study, 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Any patient who meets one or more of the following criteria cannot be included in the study 1. The patient has a current Axis I primary psychiatric diagnosis other than schizophrenia Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised DSM-IV TR criteria . 2. The patient is at significant risk of suicide and/or violent behaviour as judged by the investigator. 3. The patient has other psychiatric, neurological or behavioural disorders that may interfere with the conduct or interpretation of the study. 4. The patient has a history of moderate or severe head trauma or other neurological disorders and systemic medical diseases which are likely to affect the central nervous system functioning. 5. The patient has clinically significant unstable physical illness, e.g., neurological, haematological, cardiovascular, liver or renal diseases, pulmonary, gastrointestinal, endocrine, infectious, autoimmune, metabolic disturbance. Treated, controlled and thus stable hypertension is not considered an exclusion criterion. 6. The patient has any malignant disease or a history of malignant neoplasms, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the past five years prior to Baseline. 7. The patient has uncorrected hypothyroidism or hyperthyroidism. 8. The patient has experienced neuroleptic malignant syndrome. 9. The patient has known ischemic heart disease or history of myocardial infarction within the previous 12 months , coronary artery bypass surgery or percutaneous transluminal coronary angioplasty. 10. The patient has clinically significant ECG abnormalities as judged by the investigator. 11. The patient shows clinically significant abnormal vital signs. 12. The patient has uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension which is defined as a decrease of 30 millimeters of mercury mmHg or more in systolic blood pressure SBP , and/or a decrease of 20 mmHg or more in diastolic blood pressure DBP after approximately one minute standing compared to the previous lying blood pressure, or development of symptoms. The abnormal value should be confirmed at two separate measurements. In addition, patients with a history of repeated vasovagal syncope should be excluded. 13. The patient has clinically significant abnormal laboratory data at Baseline, or any abnormal laboratory value that could interfere with the assessment of safety. 14. The patient has a current diagnosis or history of substance except for cannabinoids, nicotine and caffeine or alcohol abuse DSM-IV TR criteria within six months prior to Baseline. 15. The patient has a current diagnosis of cannabis dependence DSM-IV TR criteria . 16. The patient has a positive urine drug screen with exception of cannabinoids and benzodiazepines obtained at Baseline visit. 17. The patient requires treatment with any disallowed medication mentioned in the protocol section 5.7, with specified time period prior to baseline or during study. 18. The patient has received electroconvulsive therapy ECT within 90 days prior to Baseline. 19. The patient has been treated with clozapine within 60 days prior to Baseline. 20. The patient has known hypersensitivity or contraindication to the use of serotonergic agents, dopamine antagonists or dopamine agonists. Severe drug allergy or any history of severe drug reaction. 21. Site personnel and their immediate families. 22. The patient,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To provide access to bifeprunox for patients with schizophrenia who have completed studies 10206 or 10265, and require continued treatment with bifeprunox, other treatments not being feasible as judged by the investigator.;Secondary Objective: To investigate the long-term safety and tolerability of bifeprunox in patients with schizophrenia.;Primary end point(s): because of the open-label nature of the present study, all efficacy analyses e.g. CGI-S will be exploratory
- Secondary Outcome Measures
Name Time Method