A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier:
NCT00604279
First received: January 17, 2008
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone palmitate (R092670)
Drug: Risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Parallel Group Comparative Study of Paliperidone Palmitate (50, 100, 150 mg eq) and Risperidone LAI (25, 37.5, or 50 mg) in Subjects With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Xian-Janssen Pharmaceutical Ltd.:

Primary Outcome Measures:
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal [ Time Frame: Baseline, Day 92 or early withdrawal ] [ Designated as safety issue: No ]
    The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.


Secondary Outcome Measures:
  • Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal [ Time Frame: Baseline, Day 92 or early withdrawal ] [ Designated as safety issue: No ]
    This PSP assesses the degree of a participant's dysfunction 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 (1, absent to 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; <= 30, functioning so poorly as to require intensive supervision.

  • Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal [ Time Frame: Baseline, Day 92 or early withdrawal ] [ Designated as safety issue: No ]
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher change scores indicate worsening.

  • Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal [ Time Frame: Baseline, Day 92 or early withdrawal ] [ Designated as safety issue: No ]
    The self-administered sleep VAS scale (0-100 millimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).

  • Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal [ Time Frame: Day 92 or early withdrawal ] [ Designated as safety issue: No ]
    A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more.


Enrollment: 452
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone palmitate
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.
Drug: Paliperidone palmitate (R092670)
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.
Active Comparator: Risperidone long acting injection (LAI)
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
Drug: Risperidone
Risperidone LAI intramuscular at a dose of 25 mg on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.

Detailed Description:

This is a randomized (assigned by chance), open-label (all people know the identity of the intervention), active-controlled, parallel-group (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter (when more than one hospital or medical school team work on a medical research study) comparative study in participants with schizophrenia. This study comprises a screening period of not more than 7 days and a 13-week open-label treatment period. Paliperidone palmitate will be administered as intramuscular injection (injection of a substance into a muscle) of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. at Day 8, flexible dose on Day 36 (50 or 100 mg eq.) and on Day 64 (50, 100 or 150 mg eq.) depending on investigator's discretion. Risperidone LAI will be administered at a dose of 25 mg at Day 8 and Day 22, flexible dose on Day 36 (25 or 37.5 mg) and Day 64 (25, 37.5, or 50 mg). Dose on Day 50 is the same as Day 36 and dose on Day 78 is the same as Day 64. Participants will receive oral risperidone tablets (1 to 6 mg/day) for the first 4 weeks of the open-label treatment period. Each participant may receive oral risperidone tablets (1 to 2 mg daily) for up to 3 weeks at Day 36 and Day 64 if the dose of risperidone LAI was increased on Day 36 and Day 64. Efficacy will primarily be assessed using the Positive and Negative Syndrome Scale (PANSS). Participants' safety will also be assessed.

  Eligibility

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

Inclusion Criteria:

  • Participants who meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening and prior medical records, written documentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
  • A total Positive and Negative Syndrome Scale (PANSS) score between 60 and 120, inclusive, at screening and baseline
  • Body mass index (BMI) of equal to or greater than 17.0 kilogram per meter square (kg/m^2)
  • Female participants must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study
  • Be capable of self-administering study medication (applies to oral supplementation) or have assistance with study medication administration consistently available throughout the first 4 weeks of the study Exclusion Criteria:
  • A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
  • A decrease of at least 25 percent in the total PANSS score between screening and baseline
  • Participants who have previously participated in this study
  • A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
  • History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604279

Locations
China
Baoding, China
Beijing, China
Guangzhou, China
Hangzhou, China
Nanjing, China
Shanghai, China
Wuhan, China
Xian, China
Sponsors and Collaborators
Xian-Janssen Pharmaceutical Ltd.
Investigators
Study Director: Xian-Janssen Pharmaceutical Ltd. Clinical Trial Xian-Janssen Pharmaceutical Ltd.
  More Information

No publications provided

Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT00604279     History of Changes
Other Study ID Numbers: CR013150, R092670PSY3008
Study First Received: January 17, 2008
Results First Received: February 21, 2013
Last Updated: June 4, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Schizophrenia
Paliperidone
Paliperidone palmitate
Risperidone
Risperidone long acting injection
R092670

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
9-hydroxy-risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 27, 2014