EUCTR2005-005501-28-DE进行中（未招募）不适用
Six week, double-blind, placebo controlled Phase III trial evaluating the efficacy, safety and pharmacokinetics of flexible doses of oral ziprasidone in adolescent subjects with schizophrenia.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 276
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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 +2.00, 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 of the protocol). 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.
- •Patients who are receiving prohibited medications are to be considered for the protocol only if discontinuation of the medication does not compromise the welfare of the patient and/or alternative medication that is allowed by the protocol is available and appropriate for the patient. Psychotropic medications should be tapered down per accepted medical practice and the specific package insert instead of being abruptly discontinued.
- •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 (eg, Norplant®), transdermal hormonal contraceptive (eg, Ortho-
- •Evra®), or an injectable contraceptive (eg, 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, eg, 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
排除标准
- •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. At the discretion of the investigator and after discussion with Pfizer, subjects with a positive urine drug screen may be eligible for admission.
- •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
- •5. Subjects who are judged by the investigator as being at imminent risk of homicide
- •6. Subjects with significant mental retardation (ie, IQ <70) that would interfere with study conduct or with the interpretation of the study assessments.
- •7. Subjects with autism or pervasive developmental disorder.
- •General Medical
- •8. Subjects with any serious, unstable illness including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic (including controlled or uncontrolled Type I diabetes), immunologic, hematologic, dermatological, oncological, or neurological disease (including any history of seizure or epilepsy). Subjects with a history of febrile seizures are eligible if no seizures have occurred during the last 3 years.
- •9. Subjects with a history of syncopal episodes (sudden loss of consciousness with loss of postural tone and not preceded by a pre-syncopal phase) or unexplained loss of consciousness. Subjects with a history of occasional syncopes of probable vasovagal origin (onset not sudden but preceded by a pre-syncopal phase, presence of predisposing factors such as blood sampling procedure, standing, hot shower, hair curling, etc) are eligible.
- •10. Subjects with any medical condition or dietary habit that has a significant potential to alter the absorption of the study drug; or subjects taking any medication that may alter drug absorption. (eg, anorexia nervosa, bulimia, chronic use of laxatives).
- •11. Subjects with uncorrected hypothyroidism or hyperthyroidism or whose thyroid
- •function and medication regimen have been stable less than 1 month.
- •12. Subjects with any screening laboratory value that deviates significantly from the upper or lower limits of the normal reference range. SGOT and SGPT must be within 2 X and total bilirubin must be within 1.5 X times of the upper limits of the reference range. Subjects with an isolated increase of unconjugated bilirubin (Gilbert’s syndrome) are eligible.
- •13. Subjects with a history of chronic hepatitis, known serologic evidence of acute hepatitis or chronic hepatitis (positive HbsAg), or subjects with known hepatitis C antibodies and elevated LFTs.
- •14. Subjects known to be HIV positive.
- •15. Subjects with clinically significant hypokalemia or hypomagnesemia not corrected and stabilized by the addition of dietary supplements or some other corrective measure prior to Baseline.
- •Cardiovascular
- •16. Subjects with a history of significant cardiovascular disease, including conditions that have previously required treatment or acute evaluation, or significant concurrent
- •cardiovascular disease, including uncontrolled hypertension (sitting diastolic pressure
- •>90 mm Hg and/or sitting systolic pressure >140 mm Hg with or without treatment),
- •hypotension, congestive heart failure, or congen
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