EUCTR2008-007800-27-BG进行中（未招募）不适用
A Prospective, Randomized, Active-controlled, Rater-blinded Study of thePrevention of Relapse Comparing Paliperidone Palmitate with Oral Risperidone inAdults with Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse
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
- 936
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
- •Subjects may be men or women between 18 and 35 years of age, inclusive.
- •Subjects must be, in the opinion of the investigator, able to understand the informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), as appropriate. All subjects must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. In addition, reasonable efforts should be made to provide information about the study to a subject’s designated contact person. Note: It is acceptable to have additional
- •signatures if required by local regulations. In addition, where permitted, if a subject
- •has an appointed legal representative, both the representative and the subject must
- •sign the form. Subjects who are unable to provide their own consent or who have
- •been involuntarily committed to psychiatric hospitalization are not eligible to enroll
- •in the study.
- •Subjects must have a current diagnosis of schizophrenia [paranoid type (295.30),
- •disorganized type (295.10), undifferentiated type (295.90), or residual type (295.60)]
- •based upon the SCID-1 according to criteria given in the Diagnostic and Statistical
- •Manual of Mental Disorders, 4th edition (DSM-IV).
- •Subjects must have had an initial index diagnosis of schizophrenia within 5 years of
- •screening. Prior medical records, written documentation, or verbal information (with
- •accompanying written documentation) obtained from previous psychiatric providers
- •must be provided.
- •Subjects must have had 4 periods of breakthrough symptoms that required a change in patient care as determined by the investigator (e.g. increase in dose, addition of a new drug, hospitalization, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, etc.) within the previous 24 months, including 1 such period within the previous 3 months.
- •Subjects must have a CGI-S score > or equal to 4 at Screening and at Stabilization Phase
- •Subjects must have scores of at least 4 (Moderate) on at least 2 of the following
- •PANSS assessment items at Screening and at the Stabilization Phase baseline visit:
- •- G9, Unusual thought content
- •- P1, Delusions
- •- P3, Hallucinatory behavior
- •- P4, Excitement
- •- P5, Grandiosity
- •- P6, Suspiciousness/persecution
- •Subjects may have a historical diagnosis of alcohol or substance abuse, excluding
- •intravenous (I.V.) use.
- •Subjects must be healthy on the basis of physical examination, medical history, vital
- •signs, and 12-lead ECG performed at screening. If there are abnormalities, the subject
- •may be included only if, after discussion with the medical monitor, the investigator
- •judges the abnormalities or deviations from normal not to be clinically significant or
- •to be appropriate and reasonable for the population under study. This determination
- •must be recorded in the subject's source documents and initialed by the investigator.
- •Subjects must be healthy on the basis of clinical laboratory tests performed at
- •screening. If the results of the serum chemistry panel, hematology, or urinalysis are
- •outside the normal reference ranges, the subject may be included only if the
- •investigator judges the abnormalities or deviations from normal to be not clinically
- •significant or to be appropriate and reasonable for the population under study. This
- •determination must be recorded in the s
排除标准
- •Subjects who are unable to provide their own consent or are involuntarily committed to psychiatric hospitalization
- •Subjects who have attempted suicide within 12 months before screening or are at
- •imminent risk of suicide or violent behavior, as clinically assessed by the investigator
- •at time of screening
- •Subjects who have a positive urine drug screen test for barbiturates, cocaine,
- •amphetamines, or opiates at screening; subjects may be re-screened 30 days after a
- •positive drug screen.
- •Subjects who are in their first episode of psychosis
- •Subjects with a psychiatric diagnosis that is due to direct pharmacological effect of a substance (e.g., a drug of abuse or medication) or a general medical condition (e.g., clinically notable hypothyroidism).
- •Subjects currently meeting criteria for any other Axis I diagnosis except substance
- •Subjects who are treatment-resistant in the judgment of the Investigator
- •Subjects with an Axis II diagnosis of Mental Retardation or Borderline Personality
- •Subjects meeting the DSM-IV definition of substance dependence (except for
- •nicotine and caffeine dependence) within 6-months prior to entry; Subjects with
- •current substance use or abuse, with the exception of intravenous drug use, will be
- •allowed to enroll.
- •Subjects with a history of neuroleptic malignant syndrome
- •Subjects with known allergies, hypersensitivity (anaphylaxis-type reaction), or
- •intolerance to paliperidone palmitate, risperidone, Risperdal®, Risperdal® Consta®, or INVEGA® or its excipients
- •Subjects with evidence of clinically significant cardiovascular, renal, hepatic,
- •gastrointestinal, neurological, endocrine, metabolic or pulmonary disease within the
- •past 6 months (as determined by medical history, clinical laboratory or ECG results,
- •or physical examination) that would increase the risk associated with taking study
- •medication or would confound the interpretation of the study
- •Subjects who received an investigational drug (including vaccines) or used an
- •investigational medical device within 30 days of SPD 1 (SPV1, stabilization
- •baseline), are currently enrolled in an investigational study, have planned use of other investigational drugs during the timeframe of the study, or have participated in more than 2 clinical trials in the past year
- •Subjects who received LAT treatment within 2 injection cycles prior to screening
- •Subject who received treatment with clozapine within 3 months of SPD1
- •Subjects receiving therapy with carbamazepine
- •Women who are pregnant or breast-feeding, or planning to become pregnant
- •Subjects with any condition that, in the opinion of the investigator, would
- •compromise the well-being of the subject or the study or prevent the subject from
- •meeting or performing study requirements
- •Employees of the investigator or study center, with direct involvement in the
- •proposed study or other studies under the direction of that investigator or study
- •center, as well as family members of the employees or the investigator
- •Subjects who have a pre-planned surgery or procedure that would interfere with the conduct of the study
研究者
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A Prospective, Randomized, Active-controlled, Rater-blinded Study of thePrevention of Relapse Comparing Paliperidone Palmitate with Oral Risperidone inAdults with Recently-Diagnosed Schizophrenia Who Are at High Risk of RelapseRecently-Diagnosed SchizophreniaMedDRA version: 9.1Level: LLTClassification code 10039626Term: SchizophreniaEUCTR2008-007800-27-CZJanssen-Cilag International NV936
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