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

• Conditions: Recently-Diagnosed Schizophrenia; MedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2008-007800-27-CZ
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 936

Inclusion Criteria

•Subjects must 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-CV according to criteria given in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
•Subjects must have had a first diagnosis of any psychotic disorder within 5 years before screening and must currently meet diagnostic criteria for schizophrenia as confirmed by administration of the SCID CV at the screening visit. Prior medical records, written documentation, or verbal information (with accompanying written documentation) obtained from previous psychiatric providers must be provided.
•Subjects must have had 3 periods of breakthrough symptoms within the previous 24 months, including 1 such period within the previous 6 months. These breakthrough symptoms must have necessitated a change in subject care (eg, hospitalization due to relapse, increases or additions of psychotropic medications, and/or increases in the frequency or intensity of subject contact required to maintain outpatient status. Other indicators presented by the clinical investigator will be reviewed on a case-by-case basis by the medical monitor).
•Subjects must have a CGI-S score =4 at Screening and at Stabilization Phase baseline.
•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 (IV) use.
•Subjects must be healthy based on 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 based on 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 inve

Exclusion Criteria

•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 (eg, a drug of abuse or medication) or a general medical condition (eg, clinically notable hypothyroidism).
•Subjects currently meeting criteria for any other Axis I diagnosis except substance abuse
•Subjects who are treatment-resistant in the judgment of the Investigator
•Subjects with an Axis II diagnosis of Mental Retardation or Borderline Personality Disorder
•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 (refer to Section 13.1, Physical Description of Study Drug(s)
•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 SPD 1
•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
•Subjects with a previous history, in the clinician’s judgment, of inadequate response to 9 OH risperidone (paliperidone) or risperidone

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified