None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Bifeprunox, in capsules, the dose will be increased progressively from 0.25 mg to 30 mg per day. It will be administered, PO, QD in the morning + Placebo, in capsule at night. This scheme will be administered for 52 weeks.
Group name:GROUP 2 Type of group
This group will be treated with Quetiapine, in capsules, the dose will be increased progressively from 25 mg to 200 mg per day, PO, BID (in the morning and at night). This scheme will be administered for 52 weeks.
Sponsors
SOLVAY PHARMACEUTICALS,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject or his authorized legal representative must understand the nature of the study and give written informed consent before performing any study procedure. 2. Each subject should be able to communicate with the study staff. 3. Primary diagnosis of schizophrenia. 4. No hospitalization for exacerbation of schizophrenia within the previous 2 months. 5. No change in antipsychotic medication and doses within the previous 8 weeks. 6. Normal physical and neurological examination, clinical history, electrocardiogram, blood biochemistry, hematology analysis, vital signs in the selection that support good general health. 7. Subjects men or women between 18 and 65 years of age. 8. Total score of the PANSS ≤ 80. 9. Subjects that have a CGI-S score ≤ 4. 10. Subjects that have a score ≤ 4 (moderate) of the following PANSS items: P2 (conceptual disorganization), P3 (hallucinatory behavior), P6 (suspicion / persecution), P7 (hostility), G8 (lack of collaboration) , G9 (unusual content of thought). 11. Subjects who have a BMI> 27 kg / m2. 12. Subjects who have a fasting triglyceride level> 130 mg / dl. 13. Women who are not breastfeeding or women without the potential to procreate. All women must present a negative serum B-HCG test before the baseline evaluation. A woman with the potential to procreate may be enrolled as long as she uses one of the medically acceptable methods of contraception.
Exclusion criteria
Exclusion criteria: 1. Active, acute, current psychotic episode or a current Axis I primary psychiatric diagnosis that is not schizophrenia, based on the DSM-IV-TR criteria. 2. Potential for violent behavior. 3. Suicidal ideas within the previous 12 months or a suicide attempt within the previous 3 years. 4. Unstable psychiatric, neurological or behavioral medical disorders, which may interfere with the conduct or interpretation of the study. 5. History of moderate or severe brain trauma or other neurological disorders and systemic clinical diseases that are likely to affect the functioning of the central nervous system. 6. Malignant disease or a history of malignant disease, within the last 5 years. 7. Current diagnosis or history of alcohol or substance abuse based on DSM-IV-TR criteria within the previous 6 months. 8. Drug control in positive urine. 9. Exposure to any investigational drug within the previous 60 days. 10. Treatment with bifeprunox in a previous study. 11. Treatment with clozapine within the previous 60 days. 12. Current treatment with depot antipsychotic medication. 13. Electroconvulsive treatment (ECT) within the previous 12 weeks. 14. Previous treatment with quetiapine within the previous year. 15. History of intolerance or failure to respond to previous treatments with quetiapine. 16. Treatment with antidepressants or mood stabilizers within the previous 2 months. 17. Subjects who need concomitant medications not allowed during the study. 18. Current evidence of a clinically significant disease, which could possibly interfere with the subject´s participation in the study. 19. Confirmed ischemic heart disease or a history of myocardial infarction (MI) within the previous 12 months. 20. Presence of QT intervals> 480 ms for men,> 500 ms for women, history of congenital prolonged QT syndrome, or risk of Torsades des Pointes. 21. Symptomatic hypotension or orthostatic hypotension. 22. History of more than one episode of vasovagal syncope. 23. Hypothyroidism or hyperthyroidism not corrected or uncontrolled. 24. Subjects who have experienced a neuroleptic malignant syndrome. 25. Reasonable probability of noncompliance with the protocol or any other reason that prohibits enrollment of the subject in the study. 26. Center staff and their close relatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Body weight will be measured with light clothing and without shoes on a scale. Measure:Average weight change. Timepoints:Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: The Scale of Positive and Negative Symptoms (PANSS) is a medical assessment designed to measure the severity of psychopathology, including 30 sections: 7 sections constitute the positive scale, 7 sections constitute the negative scale and 16 sections constitute the general scale of psychopathology. Criterion 2: Clinical Global Impression Scale - Global Improvement Subscale (CGI-I), evaluates the improvement or worsening of the subject from the baseline visit. The accounts range from 1 (improved a lot) to 7 (it got much worse). Criterion 3: The Clinical Global Impression Scale - Disease severity subscale (CGI-S), evaluates the researcher s impression of the subject s current illness. The ratings range from 1 (not sick at all) to 7 (extremely ill). Criterion 4: The Calgary Scale of Depression Rating for Schizophrenia (CDSS) Criterion 5: The Arizona Sexual Experience Scale Criterion 6: Deterioration is defined as the presence of 1 or more of the following categories: a) CGI-I ≥ 5. b) PANSS ≥ 5. c) PANSS, increase ≥ 20%. Measure:Efficacy: Changes from the baseline in 1) Total score of the PANSS. 2) CGI-I. 3) CGI-S. 4) CDSS. 5) ASEX. 6) Deterioration. Timepoints:Week 26. ; Outcome name:Quality of life is evaluated with different instruments: IWQOL-Lite (Impact of weight on the quality of life), QOL-S (Quality of life - Schizophrenia) and the Personal and Social Development Scale (PSP). Measure:Health results. Timepoints:Weeks 4, 8, 26, 52 and at the end of the treatment. ; Outcome name:Criterion 1: Peripheral blood glucose levels will be obtained after a fast of 8 hours and after 15, 45, 75 and 120 minutes after having ingested 50 g of glucose. Criterion 2: Evaluated by computed tomography (CT). Criterion 3: Fasting blood lipid, glucose and insulin levels. The BMI will be calculated based on weight and height. Measurement with a tape measure around the body, in the thinn | — |
Countries
Argentina, Canada, Chile, Czech Republic, Estonia, Finland, Germany, Hungary, Latovia, Lithuania, Peru, Slovakia, South Africa
Outcome results
None listed