An Efficacy Study of Paliperidone for the Prevention of Relapse in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01662310
First received: March 29, 2012
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to evaluate the efficacy, tolerability and safety of paliperidone extended release (ER) tablets (between 3 to 12 mg, once a day) in the prevention of relapse in schizophrenia patients.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone ER 3 mg
Drug: Paliperidone ER 6 mg
Drug: Paliperidone ER 9 mg
Drug: Paliperidone ER 12 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Paliperidone Extended Release Tablets for the Prevention of Relapse in Subjects With Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Time to relapse [ Time Frame: Up to 74 weeks after the last patient is randomized ] [ Designated as safety issue: No ]
    A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25% increase in PANSS total score for 2 consecutive assessments for patients who score >40 at randomization, or a 10-point increase for patients who scored ≤40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (P1, P2, P3, P6, P7 or G8) to ≥5 for patients who scored ≤3 at randomization, or to ≥6 for patients with initial score of 4.


Secondary Outcome Measures:
  • Positive and Negative Syndrome (PANSS) Scale [ Time Frame: Up to 74 weeks after the last patient is randomized ] [ Designated as safety issue: No ]
    PANSS is a 30-item scale which provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), negative subscale (7 items), and the general psychopathology subscale (16 items).

  • Clinical global impression - severity (CGI-S) Scale [ Time Frame: Up to 74 weeks after the last patient is randomized ] [ Designated as safety issue: No ]
    The CGI-S rating scale is used to rate the severity of a patients condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

  • Personal and social performance (PSP) Scale [ Time Frame: Up to 74 weeks after the last patient is randomized ] [ Designated as safety issue: No ]
    The PSP scale assesses the degree of difficulty a patient exhibits over a 1-month period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent, to vi, very severe) in each of the 4 domains.

  • Sleep visual analog scale (Sleep VAS) [ Time Frame: Up to 74 weeks after the last patient is randomized ] [ Designated as safety issue: No ]
    This scale assess quality of sleep and daytime drowsiness by placing marks on lines to represent how well they had slept in the previous 7 nights (very badly to very well) and how often they had felt drowsy in the past 7 days (not at all to all the time).

  • Number of patients with adverse events [ Time Frame: Up to 74 or 98 weeks after the last patient is randomized ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: June 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone extended release (ER)
Paliperidone is given in 4 flexible doses at 3,6, 9 and 12 mg.
Drug: Paliperidone ER 3 mg
Type=exact number, unit=mg, form=tablet, route =oral. The patients will receive once daily dose of paliperdone 3 mg.
Drug: Paliperidone ER 6 mg
Type=exact number, unit=mg, form=tablet, route =oral. The patients will receive once daily dose of paliperdone 6 mg.
Drug: Paliperidone ER 9 mg
Type=exact number, unit=mg, form=tablet, route =oral. The patients will receive once daily dose of paliperdone 9 mg.
Drug: Paliperidone ER 12 mg
Type=exact number, unit=mg, form=tablet, route =oral. The patients will receive once daily dose of paliperdone 12 mg.
Placebo Comparator: Placebo Drug: Placebo
Type=exact number, unit=mg, form=tablet, route =oral. The patients will receive once daily dose of placebo during the double-blind treatment phase only.

Detailed Description:

This is a double-blind (neither physician nor patient knows the name of the assigned drug), randomized (patients are assigned to treatment by a chance), placebo-controlled, parallel-group study of paliperidone ER tablets. The study will consists of 6 phases: 14 days of screening phase, 8 weeks of open-label run-in phase (patients will be flexibly dosed with paliperidone ER once daily in a dose range of 3 mg to 12 mg), 6 weeks of stabilization phase (patients will continue to receive the fixed dose of paliperidone ER), double-blind (DB) phase of various length (patients will be randomly assigned in a 1:1 ratio to receive either paliperidone ER or placebo and this phase will be completed after 86 relapse events are observed or if the study is positive at the interim analysis), 6 months of open-label extension (patients who experience a relapse event or who remain relapse free for the entire duration of the double-blind Phase and patients who are enrolled at the time the study is terminated, will be eligible for this phase. All patients will be treated with paliperidone ER and safety and tolerability information will be collected during this phase) phase and 6 months of follow-up phase (patients who withdraw during the DB phase for any reason other than relapse will be followed for 6 months or until they experience a relapse). Patients safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV-TR)
  • Have experienced an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120 inclusive, at screening and baseline
  • Women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), practicing a highly effective method of birth control, if sexually active
  • Men must be using a highly effective method of birth control and must not donate sperm during the study and for 3 months after receiving the last dose of study drug
  • Be willing and capable to complete the questionnaires and able to take oral medications independently

Exclusion Criteria:

  • Has drug dependence diagnosis according to DSM-IV (excluding nicotine and caffeine dependence) within 6 months before screening
  • Patients with Crohn's disease and hepatic or renal diseases
  • Has had relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular dysfunction), renal, hepatic, endocrine, or immunologic diseases
  • Has had history neuroleptic malignant syndrome (the disorder caused by antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)
  • Has had known or suspected Stevens Johnson Syndrome (an immune disease with symptoms of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin, carbamazepine, barbiturates, or lamotrigine
  • Had been treated with clozapine for treatment refractory or treatment resistant schizophrenia
  • Has significant risk of suicide or homicidal behavior, or significant risk of deliberate self harm or harm to others
  • Has taken isocarboxazid, phenelzine, selegiline and tranylcypromine within 4 weeks before screening
  • Has received electroconvulsive therapy within 60 days before screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662310

Locations
China
Baoding, China
Beijing, China
Changsha, China
Chengdu, China
Guangzhou, China
Harbin, China
Kunming, China
Nanjing, China
Shanghai, China
Taiyuan, China
Tianjin, China
Wuhan, China
Xi'An, China
Xian, China
Xinxiang, China
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01662310     History of Changes
Other Study ID Numbers: CR100427, R076477-SCH-3041
Study First Received: March 29, 2012
Last Updated: October 15, 2013
Health Authority: China: Food and Drug Administration
China: Ethics Committee

Keywords provided by Janssen Research & Development, LLC:
Schizophrenia
Paliperidone
Psychotic disorder
Delusions
Relapse prevention

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 23, 2014