Schizophrenia MedDRA version: 8.0 Level: LLT Classification code 10039626
Conditions
Interventions
Trade Name: Zeldox
Product Name: Zeldox
Product Code: NA
Pharmaceutical Form: Capsule*
INN or Proposed INN: Ziprasidone Hydrochloride
CAS Number: 138982-67-9
Current Sponsor code: CP-88,059-1
Other de
Sponsors
Pfizer AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject and the authorized legal representative must understand the nature of the study and be able to comply with protocol requirements. The representative must sign an Informed Consent Document and the subject must provide Written Assent. 2. The subject (male or female) must be between 13-17 (inclusive) years of age at screening. 3. The subject must have a primary diagnosis of schizophrenia as defined by DSM-IV criteria and confirmed by the KID-SCID. 4. The current symptoms must have been present for at least 7 days prior to Screening. Subjects with a first episode of psychosis are allowed. 5. At the screening and baseline visits, subjects must have a BPRS-A score = 35 and a score of = 4 on at least 1 of the following items: unusual thought content (ie, delusions), hallucinations, suspiciousness, or conceptual disorganization. 6. In the investigator’s opinion, 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, inclusive. 8. The subject is willing and able to discontinue any medications that are prohibited in this study (see Concomitant Medications table, Section 5.5). Any such medications must be discontinued at least 4 half-lives (or 10 ten days, whichever is less) prior to the administration of double-blinded study medication. 9. Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception and meet all of the following criteria: a) Are instructed and agree to avoid pregnancy during the study. b) Have a negative serum pregnancy test (ß-HCG) at screening and baseline. c) Use one of the following birth control methods: · an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g. Norplant), transdermal hormonal contraceptive (e.g. Ortho-Evra), or an injectable contraceptive (e.g. Depo-Provera) for at least one month prior to entering the study and will continue its use throughout the study; or · a barrier method of contraception, e.g., condom and/or diaphragm with spermicide while participating in the study. · abstinence for at least 3 months before the start of the study and intention to abstain from sexual activity during the study period. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Psychiatric : 1. Subjects who are clinically stable on treatment regimens that are being well tolerated. 2. Subjects with substance-induced psychotic disorder or whose behavioral disturbance is thought to be due to substance abuse. 3. Subjects with DSM-IV defined psychoactive substance or alcohol abuse/dependence (does not apply to nicotine or caffeine) within the preceding 1 month. 4. Subjects with a rating of 7 on the single Suicidal Ideation item (item #13) from the CDRS-R, or who are otherwise judged by the investigator as being at imminent risk of suicide. 5. Subjects who are judged by the investigator as being at imminent risk of homicide 6. Subjects with significant mental retardation (i.e. IQ 90 mm Hg and/or sitting systolic pressure > 140 mm Hg with or without treatment), hypotension, congestive heart failure, or congenital heart disease. 18. Subjects with a history of cardiac arrhythmias, conduction abnormalities or known personal history of QT prolongation (including congenital long QT syndrome). 19. Subjects with a known genetic risk for prolonged QT syndrome 20. Subjects with a clinically significant ECG abnormality at Screening or Baseline 21. Subjects with persistent QTc (Fridericia) = 460 msec at Screening or Baseline. Medications; 22. Subjects taking any medications not allowed by the Concomitant Medication Table (Section 5.5). Medications s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change from baseline to Week 6 in Brief Psychiatric Rating Scale - Anchored (BPRS-A) total score.;Main Objective: 1. To establish efficacy of oral ziprasidone compared with placebo in the treatment of adolescent subjects with schizophrenia, as measured by the change from baseline to Week 6in Brief Psychiatric Rating Scale - Anchored (BPRS-A) total score. 2. To evaluate the safety and tolerability of oral ziprasidone over 6 weeks in the treatment of adolescent subjects with schizophrenia.;Secondary Objective: 1. To evaluate efficacy of oral ziprasidone as compared with placebo in the treatment of adolescent subjects with schizophrenia, as measured by · Change from baseline in Positive and Negative Syndrome Scale (PANSS) - total score, positive and negative subscales. · Change from baseline in Clinical Global Impression of Severity (CGI-S) score. · Clinical Global Impression of Improvement (CGI-I) score. 2. To characterize the population pharmacokinetics and pharmacokinetics/pharmacodynamics (PK/PD) of oral ziprasidone in adolescent subjects with schizophrenia, including PK/PD analysis for efficacy (BPRS-A) and safety (QTc) measurements. | — |
Countries
Germany, Sweden
Outcome results
None listed