None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Ziprasidone in capsules of 20 mg, 40 mg and 60 mg. There will be an objective dose of 120-160 mg / day for individuals ≥
45 kg and 60-80 mg / day for subjects <45 kg. This target dose must be achieved on the 14th day of treatment. The dose increase will be done in a graduated way, approximately 20 mg every 2 days.
In
GROUP 2 Type of group
This group will be treated with Ziprasidone Placebo, presented in capsules. A fictitious dose increase will be carried out every 2 days until reaching a target dose at 14 weeks. Once the target dose is reached, it will continue until the treatment is completed for 6 weeks.
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject and the authorized legal representative must understand the nature of the study and must be able to obey the protocol requirements. 2. The subject must be between 13 and 17 years old at the time of selection. 3. The subject must have a primary diagnosis of schizophrenia. 4. Current symptoms must have been present for at least 7 days prior to selection. 5. At screening and baseline visits, subjects must have a BPRS-A score ≥ 35 and a score of ≥ 4 in at least one of the following concepts: thinking of strange content, hallucinations, mistrust, or conceptual disorganization. 6. The subject must be likely to benefit from antipsychotic therapy. 7. The subject must have a Body Mass Index (BMI) z-score between -1.65 and +1.65. 8. The subject is willing and able to discontinue any medication that is prohibited in this study. 9. Women with potential for maternity may be included, provided they are not pregnant, or breastfeeding, and are practicing effective contraception.
Exclusion criteria
Exclusion criteria: 1. Subjects that are clinically stable, with treatment regimens that are being well tolerated. 2. Subjects with a substance-induced psychopathic disorder or from whom the behavioral disturbance is thought to have been due to the abuse of a substance. 3. Subjects with psychoactive substance abuse. 4. Subjects with an evaluation of 7 in the concept of Suicide Planning. 5. Subjects who are at imminent risk of suicide. 6. Subjects with significant mental retardation. 7. Subjects with autism or strong developmental disorder. 8. Subjects with any serious and unstable disease. 9. Subjects with a history of episodes of syncope or unexplained loss of consciousness. 10. Subjects with any medical condition or dietary habit, that have an important potential to alter the absorption of the study drug, or the subjects who are taking any medication that could alter its absorption. 11. Subjects with uncorrected hypothyroidism or hyperthyroidism, or whose thyroid function and medication regimen has been stable for less than one month. 12. Subjects with some selection laboratory value that deviates significantly from the limits of the normal reference range. 13. Subjects with K, Mg or Ca values ​​below the normal range. 14. Subjects with a history of chronic hepatitis, identified serological evidence of acute hepatitis or chronic hepatitis, or subjects with identified hepatitis C antibodies and elevated LFTs. 15. Subjects who identify themselves as HIV positive. 16. Subjects with clinically significant hypokalemia or uncorrected hypomagnesemia and stabilized by the addition of food supplements or some other corrective measure, before the baseline. 17. Subjects with a history of important cardiovascular disease. 18. Subjects with a history of cardiac arrhythmias, conduction abnormalities or personal history of QT segment prolongation. 19. Subjects with an identified genetic risk of prolonged QT syndrome. 20. Subjects with clinically significant ECG abnormalities at the screening visit or at the baseline visit. 21. Subjects with a persistent QTc ≥ 460 msec at the screening visit or at the baseline visit. 22. Subjects who are taking any medication not allowed. 23. Subjects who received clozapine for 12 weeks, deposit antipsychotics for 4 weeks, or an inhibitor of monoamine oxidase during the 2 weeks prior to the baseline visit. 24. Subjects identified with medical history or hospitalization records of having used phencyclidine during the 30 days prior to the screening visit. 25. Subjects that require treatment with drugs that have been observed to prolong the QT interval. 26. Subjects who received a research drug during the 4 weeks prior to the baseline visit. 27. Subjects who received ziprasidone in a previous clinical study. 28. Subjects who were identified with ziprasidone allergy. 29. Subjects with a history of induced antipsychotic EPS that do not respond to antiparkinson medication. 30. Subjects with a previous episode of neuroleptic malignant syndrome or a previous hypersensitivity to antipsychotic agents. 31. Subjects with a history of no response to ziprasidone, after a period of adequate treatment, with doses between 120-160 mg per day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Application of the Brief Scale of Psychiatric Evaluation - Fixed (BPRS-A): It is a scale designed to assess the change in the severity of psychopathology focusing on symptoms that are common in patients with psychotic disorders. It consists of 18 sections that include somatic concern, anxiety, emotional withdrawal, disorganization, imaginary behavior, feelings of guilt, suspicion, disorientation, tension, mannerisms and poses, affectation, depressive moods, hostility, motor delay, lack of cooperation, thought of strange content, obtuse affection, and excitement. Sections are rated on a 7-point scale. Measure:Change in the baseline in the rating in the BPRS-A. Timepoints:Week 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Positive and Negative Syndrome Scale (PANSS) is a medical assessment designed to measure the severity of psychopathology. The PANSS includes 30 sections: 7 sections constitute the positive scale (cheating, conceptual disorganization, hallucinatory behavior, etc.), 7 sections constitute the negative scale (obtuse affect, emotional withdrawal, poor relationship, and passive / apathetic social withdrawal), and 16 sections constitute the general scale of psychopathology. Criterion 2: 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 3: 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). Measure:1) Change in the baseline in the total score in the PANSS, the positive subscale and the negative subscale. 2) Change of the grade of the baseline in the CGI-S. 3) Change of the CGI-I net score from the baseline. Timepoints:Week 6 ; Outcome name:Criterion 1: Child Global Assessment Scale (CGAS): It is an element of evaluation of global clinical assessment based on children s symptoms and social development in family, school and community settings. The rating has a range of 1-100. Below 70 are considered in the normal range. Criterion 2: Child Health Questionnaire (CHQ): It is a tool that allows to know the quality of life of the subject related to their health and its development, contains 15 evaluation subscales. Criterion 3: School Placement Questionnaire: Answered by parents or guardian. Information about where the patient is currently studying, if the subject is enrolled in the school or is planning to enroll if he is on summer vacation or school holidays, regularly where he enrolls, and how | — |
Countries
Canada, Colombia, Costa Rica, Germany, India, Malasya, Mexico, Peru, Russian Federation, Singapore, Sweden, Ukraine, United States
Outcome results
None listed