Schizophrenia MedDRA version: 8.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Product Name: Bifeprunox
Product Code: Lu 02-754/DU127090
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bifeprunox
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
20 -
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: Quetiapine
Product Code: -
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN
100-
Pharmaceutical form of the placebo: Capsule*
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) diagnosis of Schizophrenia (codes 295.10, 295.20, 295.30, 295.60, 295.90) - The subject has had documented insufficient tolerability of the current antipsychotic treatment and/or low everyday functioning and/or residual symptoms - The subject has a CGI-S score of less than or equal to 4 (moderately ill) at Screening and Baseline - The subject has a total score on the PANSS less than or equal to 80 at Screening and Baseline - The subject has a score of less than or equal to 4 (moderate) of the following PANSS items at screening and Baseline: P2 (conceptual disorganisation); P3 (hallucinatory behaviour); P6 (suspiciousness/persecution); P7 (hostility); G8 (uncooperativeness); G9 (unusual thought content) - 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 treatment with antipsychotic agent(s) has been kept unchanged (with references to compound(s) and dose increase) within 8 weeks prior to Screening - The subject has had no documented acute exacerbation within 8 weeks prior to Screening 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has a current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV TR criteria). 2. The subject is at significant risk of suicide defined as - in the 12 months prior to Screening, significant risk of suicide according to the investigator judgment, and/or - a suicide attempt within 3 years prior to Screening. 3. The subject has shown violent behaviour within 12 months prior to Screening, according to the investigator’s judgment. 4. The subject has other psychiatric, neurological or behavioural disorders that may interfere with the conduct or interpretation of the study. 5. The subject 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. 6. The subject has known ischaemic heart disease or a history of myocardial infarction (within the previous 12 months), coronary artery bypass surgery or percutaneous transluminal coronary angioplasty. 7. The subject has a history of neuroleptic malignant syndrome. 8. The subject has an uncorrected hypothyroidism or hyperthyroidism. 9. The subject has/has had a current diagnosis or history of substance (except nicotine, caffeine) or alcohol abuse based on DSM-IV TR criteria within six months prior to Screening. 10. The subject has a positive urine drug screen at screening with the exception that positive result for opioids, cannabinoids and benzodiazepines will be evaluated by the Investigator and sponsor medical expert on the potential impact for study participation. 11. The subject 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. 12. The subject has within 2 months prior to Screening received antidepressants or mood-stabiliser (specified in Appendix II). 13. The subject uses disallowed medication (specified in Appendix II, or it is anticipated that the subject will require treatment with at least one of the disallowed concomitant medications during the study). 14. The subject 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 is not considered an exclusion criterion. 15. The subject 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 five years prior to Screening. 16. The subject has clinically significant abnormal vital signs. 17. The subject has uncontrolled or symptomatic hypotension, or orthostatic hypotension which is defined as decrease of 30 mmHg or more in systolic blood pressure (SBP) and/or decrease of 20 mmHg or more in diastolic blood pressure (DBP) after approximately one 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. 18. The subject has a history of repeated vasovagal syncope. 19. The subject has one or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically sig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to show superiority of bifeprunox to placebo with regard to time to impending deterioration.;Secondary Objective: - To compare long-term safety in terms of cardiovascular risk factors (weight, waist circumference, fasting blood lipids, HbA1c, fasting blood glucose, blood pressure) of bifeprunox to that of placebo and quetiapine - To determine and compare the long-term effect on functional outcomes, quality of life and treatment adherence of bifeprunox to that of placebo and quetiapine ;Primary end point(s): Impending deterioration, prospectively defined as fulfilment of one or more of the following criteria: - A Clinical Global Impression of Improvement (CGI-I) score more than or equal to 5 (at least minimally worse), or - A score more than or equal to 5 (at least moderately severe) on PANSS item P7 (hostility) and/or G8 (uncooperativeness) or - A more than or equal to 20% increase in PANSS total score from Baseline | — |
Countries
Greece
Outcome results
None listed