A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate with Oral Risperidone in Adults with Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-007800-27-BG
• Date of registration: 19/11/2009
• Prospective Registration: No
• Primary sponsor: Janssen-Cilag International NV
• Public title: A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate with Oral Risperidone in Adults with Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse
• Scientific title: A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate with Oral Risperidone in Adults with Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse
• Date of first enrolment: 13/11/2009
• Target sample size: 936
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007800-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Bulgaria, Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
• 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
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 (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
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 (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
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
• 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Recently-Diagnosed Schizophrenia
MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia

Intervention(s)

Product Name: Palperidone palmitate
Product Code: R092670 (F013)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: paliperidone palmitate
CAS Number: 199739-10-1
Current Sponsor code: R092670; JNJ-16977831-AAA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Product Name: Palperidone palmitate
Product Code: R092670 (F013)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Paliperidone Palmitate
CAS Number: 199739-10-1
Current Sponsor code: R092670; JNJ-16977831-AAA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Product Name: Palperidone palmitate
Product Code: R092670 (F013)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: paliperidone palmitate
CAS Number: 199739-10-1
Current Sponsor code: R092670; JNJ-16977831-AAA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Product Name: Palperidone palmitate
Product Code: R092670 (F013)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: paliperidone palmitate
CAS Number: 199739-10-1
Current Sponsor code: R092670; JNJ-16977831-AAA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: RISPERDAL
Product Name: Risperidone - film-coated tablet - 1 mg
Product Code: R064766 (F05)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Risperidone
CAS Number: 106266-06-2
Current Sponsor code: R064766
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: RISPERDAL
Product Name: Risperidone - film-coated tablet - 2 mg
Product Code: R064766
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Risperidone
CAS Number: 106266-06-2
Current Sponsor code: R064766
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Trade Name: RISPERDAL
Product Name: Risperi

Primary Outcome(s)

Primary end point(s): A subject will be considered to have completed the study if he or she has completed assessments at Week 104, the end of the Relapse Prevention Phase.
If a subject's study treatment must be discontinued before the end of the treatment regimen, this will not result in automatic withdrawal of the subject from the study.

Main Objective: The primary objective of this study is to assess the efficacy of paliperidone palmitate
compared with oral risperidone in delaying time to relapse in subjects recently
diagnosed with schizophrenia who are at high risk of relapse.

Secondary Objective: Secondary objectives of this study are the following:
• Evaluation of the impact of paliperidone palmitate compared with oral risperidone
with respect to personal and social functioning (Personal and Social Performance
Scale; PSP).
• Assessment of the safety and tolerability of paliperidone palmitate in this study
population through monitoring adverse events, laboratory tests, vital signs including
weight, physical examinations, movement disorders (Extrapyramidal Symptom
Rating Scale-abbreviated, ESRS-A), sexual functioning (Arizona Sexual Experiences
Scale; ASEX), and suicidality (InterSePT Scale for Suicidal Thinking-Plus, ISSTPlus).

Secondary ID(s)

2008-007800-27-CZ

R092670-SCH-3004