Schizophrenia MedDRA version: 10.0 Level: LLT Classification code 10039626 Term:
Conditions
Interventions
Product Name: Bifeprunox
Product Code: Lu02-754/DU127090
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bifeprunox
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
20-mg
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Quetiapine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapi
100
300-mg
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject has a primary diagnosis of schizophrenia according to current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR: codes 295.10, 295.20, 295.30, 295.60, 295.90). .The subject has a CGI-S score of ³ 4 (moderately ill) at screening and baseline. ·The subject has a PANSS total score ³ 60 at screening and baseline. ·The subject is either an inpatient, partially hospitalised, or outpatient for whom the centre can document at least monthly contacts (personal or by telephone) during a minimum of 3 months prior to screening. ·The subject’s antipsychotic treatment has been kept as follows: -At screening: the antipsychotic medication(s) has/have remained the same within 8 weeks prior to screening -At baseline: the antipsychotic medication(s) has/have not been changed (agent(s) and dose(s) between screening and baseline. ·The subject is in a maintenance phase and has not had an acute exacerbation according to the investigator’s judgement. -At screening: within 8 weeks prior to screening -At baseline: between screening and baseline (4 weeks). -The subject has a primary diagnosis of schizophrenia according to current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR: codes 295.10, 295.20, 295.30, 295.60, 295.90). 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The sb has a current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria). 2. The sb is at significant risk of suicide defined as - in the 12 months prior to screening, at significant risk of suicide according to the investigator judgment, and/or - a life threatening suicide attempt within 3 years prior to screening. 3. The sb has shown violent behaviour within 12 months prior to screening, according to the investigator’s judgment. 4. The sb is treatment resistant to antipsychotic treatment, according to investigator’s judgment. 5. The sb has been treated with clozapine within 60 days prior to screening. 6. The sb has other psychiatric, neurological or behavioural disorders that may interfere with the conduct or interpretation of the results of the study. 7. The sb 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. 8. The sb has known ischemic heart disease or a history of myocardial infarction (within the previous 12 months), coronary artery bypass surgery or percutaneous transluminal coronary angioplasty. 9. The sb has a history of neuroleptic malignant syndrome. 10. The sb has an uncorrected hypothyroidism or hyperthyroidism. 11. The sb has/has had a current diagnosis or history of substance (except nicotine, caffeine) or alcohol abuse based on DSM-IV-TR criteria within 6 months prior to screening. 12. The sb has a positive urine drug screen at screening with the exception that positive results for opioids, cannabinoids and benzodiazepines will be evaluated by the investigator and Lundbeck medical expert on the potential impact for study participation. 13. The sb has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to or has other contraindications to serotonergic agents, dopamine antagonists or dopamine agonists. 14. The sb has within 2 months prior to screening received antidepressants or mood-stabiliser (specified in Appendix II). 15. The sb uses disallowed medication (specified in Appendix II), or it is anticipated that the sb will require treatment with at least one of the disallowed concomitant medications during the study. 16. The sb has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, haematological, autoimmune or metabolic disturbance other than those originating from the antipsychotic treatment. Adequately treated hypertension and diabetes are not considered an exclusion criterion. 17. The sb has a malignant disease or a history of malignant disease, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the past 5 years prior to screening. 18. The sb has clinically significant abnormal vital signs. 19. The sb has uncontrolled or symptomatic hypotension, or orthostatic hypotension which is defined as a decrease of 30 mmHg or more in systolic blood pressure and/or a decrease of 20 mmHg or more in diastolic blood pressure after approximately 1 minute in upright position, compared to the previous supine blood pressure or development of symptoms. The abnormal value should be confirmed at two separate measurements. 20. The sb has a history of repeated vasovagal syncope. 21. The sb has one or more laboratory values outside the normal range, based on the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to show superior efficacy of fixed doses of bifeprunox (20 mg/day) versus placebo following 12 weeks of treatment in subjects with schizophrenia inadequately controlled in the maintenance phase. ;Primary end point(s): · Change in PANSS total score from baseline to Week 12, using last observation carried forward (LOCF);Secondary Objective: Key secondary objective: To show non-inferior efficacy of fixed doses of bifeprunox (20 mg/day) versus fixed doses of quetiapine (600 mg/day) following 12 months of treatment in subjects with schizophrenia inadequately controlled in the maintenance phase. Other secondary objectives: To compare the safety and tolerability of 12 weeks treatment with fixed doses of bifeprunox (20 mg/day) to that of placebo and quetiapine (600 mg/day) To compare the safety and tolerability of 12 months treatment with fixed doses of bifeprunox (20 mg/day) to that of quetiapine (600 mg/day) To determine and compare the effect on functional outcomes, quality of life and treatment compliance of 12 weeks treatment with fixed doses of bifeprunox (20 mg/day) to that of placebo and quetiapine (600 mg/day) To determine and compare the effect on functional outcomes, quality of life and treatment compliance of 12 months treatment with fixed doses of bifeprunox (20 mg/day) to that of quetiapine (600 mg/day) | — |
Countries
Bulgaria, Greece
Outcome results
None listed