SB-773812 administered in adults with schizophrenia
- Conditions
- -F20F20
- Registration Number
- PER-066-05
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. The subject, or a legally authorized representative, if so required, agrees to participate in the study and signs a written informed consent form.
2. The subject is a man or woman and is between 18-65 years old.
3. A female subject is eligible to enter and participate in this study if one of two criteria apply: a) The subject does not have the possibility of becoming pregnant. b) If the subject has the possibility of becoming pregnant, it must present a negative result in the pregnancy blood test, negative in the urine strip test for pregnancy and agree to commit to the continued use of one of the methods of contraception accepted.
4. The subject meets the diagnostic criteria for schizophrenia.
5. The subject requires hospitalization.
6. The subject has a total score of PANSS of at least 70.
7. The subject is considered by the researcher as reliable and likely to cooperate with the evaluation procedures.
8. The subject demonstrates an adequate command of the primary language used in the study evaluations, both written and spoken.
9. Subject has a body weight> 46 kg (male)> 41 kg (female) and BMI within the range 18.5-33.0 kg / m2.
1. That the subject is in his first episode of schizophrenia.
2. That the subject has other psychotic disorders.
3. The subject has a total initial score in PANSS that has improved by more than 20% from the measurement in the Selection visit.
4. That the condition of the subject is due to the direct physiological effects of a substance or a general medical condition.
5. That the subject has a history of substance dependence within 3 months or history of substance abuse within the previous month.
6. That the subject has a history of autistic disorder or other existing disorder in development.
7. Subjects with chronic brain disease.
8. That the subjects have an unstable medical disorder; or a disorder that interferes with the action, absorption, distribution, metabolism, or excretion of an experimental compound; or interfere with the accurate assessment of safety or efficacy.
9. That the subject has a history of epilepsy or other convulsive disorder.
10. That the subject has a history of myocardial infarction during the year prior to the initial visit.
11. That the subject has clinically significant abnormalities in hematology, blood chemistry, ECG, or physical examination.
12. That the subject has any laboratory abnormality that is clinically significant.
13. That the subject has a QTc interval> 450 msec.
14. The subject has liver dysfunction.
15. That the subject has the creatine phosphokinase (CPK) greater than five times the upper limit.
16. That the subject requires, while participating in the study, any of the medications that are specifically prohibited in the protocol.
17. That the subject has taken neuroleptics from deposit within one cycle plus one week prior to the Exploration visit.
18. That the medical history of the subject suggests that the subject was not sensitive to two or more adequate trials of antipsychotic treatments during the last 2 years. Or do not be sensitive to clozapine.
19. That the subject presents a serious suicide or homicide risk.
20. The subject is a woman who has a positive BhCG blood test result of pregnancy or who is breastfeeding or is planning to become pregnant during the month following the final dose of medication in the study.
21. That the subject is currently participating in another clinical trial in which he / she is or will be exposed to a research or non-research device or drug, or has done so during the previous month.
22. That the subject is adequately stabilized in his current treatment.
23. That the subject is unable to take Olanzapine based on prescribed information or that the subject has had a hypersensitivity reaction to Olanzapine.
24. That the subject has high risk factors of poor glycemic control / diabetes mellitus or shows fasting blood glucose> 1.5 times at the upper limit.
25. That the subject has type I or II diabetes, or any condition that could be considered pre-diabetic.
26. The subject has a history of allergic reaction or medically significant adverse effects to the study drug, excipients, or closely related compounds.
27. That the subject has a history of or is at high risk of developing adverse cerebrovascular events.
28. That the subject has received treatment for electroconvulsive shock (ECT), vagal nerve stimulation (VNS), or transcranial magnetic stimulation (TMS) within 6 months prior to the initial visit.
29. The subject presents or
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method