An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT00757705
First received: September 19, 2008
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to explore the maintained efficacy, tolerability, and safety of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with other oral atypical antipsychotic medication.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone ER
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Prospective Trial to Evaluate the Tolerability, Safety and Maintained Efficacy of a Transition to Paliperidone ER in Subjects With Schizophrenia Previously Unsuccessfully Treated With Other Oral Antipsychotics

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.


Secondary Outcome Measures:
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity.

  • Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.

  • Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).

  • Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.

  • Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24 [ Time Frame: Baseline, Week 24 ] [ 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".

  • Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.

  • Number of Participants With Satisfaction With the Study Treatment [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor).

  • Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time).


Enrollment: 299
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone Extended-Release (ER) Drug: Paliperidone ER
Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the individual participant's clinical response to and tolerability of the study drug.
Other Names:
  • R076477
  • Invega

Detailed Description:

This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), 24-week study. Participants can be transitioned to an effective dose of paliperidone ER from any oral antipsychotic medication without the need for titration due to lack of efficacy, lack of tolerability or safety, lack of compliance or other reason. A transition period of maximum 4 weeks will be allowed. Throughout the study, participants will receive flexible dose of 3 to 12 milligram (mg) of paliperidone once daily orally for 24 weeks. Dose adjustment will be done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug. Assessments of efficacy will be performed at screening and after 2, 4, 12 and 24 weeks. Efficacy will primarily be evaluated by means of Positive and Negative Syndrome Scale (PANSS). Participants' safety will also 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:

  • Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
  • Participant has been given an adequate dose of an appropriate oral atypical antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
  • Participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
  • Female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must also have a negative urine pregnancy test at screening
  • Male or female, aged greater than or equal to 18 years

Exclusion Criteria:

  • Participants on clozapine, any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months
  • Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
  • Participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
  • Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
  • Participants with a current use or known history (over the past 6 months) of substance dependence except for nicotine, caffeine, and betal nut according to DSM-IV Criteria
  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: NCT00757705

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

No publications provided

Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00757705     History of Changes
Other Study ID Numbers: CR014308, R076477SCH4033
Study First Received: September 19, 2008
Results First Received: February 5, 2014
Last Updated: February 5, 2014
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Johnson & Johnson Taiwan Ltd:
Schizophrenia
Paliperidone Extended-Release

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

ClinicalTrials.gov processed this record on October 23, 2014