跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2005-005501-28-SE
EUCTR2005-005501-28-SE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.

Pfizer AB0 个研究点目标入组 276 人开始时间: 2005年12月19日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
相关药物

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
Pfizer AB
入组人数
276
研究概览入排标准研究者记录与标识符相似试验

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 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

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.
  • •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 < 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).
  • •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.
  • •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.
  • •13.Subjects with screening K+, Mg++ or Ca++ below the normal range.
  • •14.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.
  • •15.Subjects known to be HIV positive.
  • •16.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.
  • •17.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 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

研究者

发起方
Pfizer AB

相似试验

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.Schizophrenia
EUCTR2005-005501-28-DEPfizer Pharma GmbH276
已完成
不适用
Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia-F209 Schizophrenia, unspecifiedSchizophrenia, unspecifiedF209
PER-102-06PFIZER S.A.,
已完成
1 期
A Phase I study of inhaled PB01 in healthy male volunteers to assess the anti-inflammatory effects of PB01 on lung inflammation.Airway inflammation and fibrosisRespiratory - Other respiratory disorders / diseases
ACTRN12616000496415Paranta Biosciences Ltd24
Unknown
1 期
A phase I clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjects
CTRI/2012/05/002691Piramal Healthcare Limited96
进行中（未招募）
1 期
Safety, tolerability, pharmacokinetics, and pharmacodynamics of single/multiple doses of IMVT-1402 in healthy participants and participants with autoimmune diseases
ISRCTN11659633Immunovant Sciences GmbH168