A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT01577160
First received: April 12, 2012
Last updated: November 25, 2013
Last verified: November 2013

April 12, 2012
November 25, 2013
May 2008
April 2009   (final data collection date for primary outcome measure)
Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.
The change from baseline in Clinical Global Impression-improvement (CGI-I) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
CGI-I rating scale rates the change in the patient's mental state on a 7-point scale rating from 1 (very much improved) to 7 (very much worse) compared with baseline.
Complete list of historical versions of study NCT01577160 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ 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 scores indicate worsening.
  • Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
  • Change From Baseline in Personal and Social Performance (PSP) Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ 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 Drug Attitude Inventory (DAI-10) Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
  • The change from baseline in Clinical Global Impression-severity (CGI-S) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
  • The proportion of patients who evaluated as "1.Very much improved" or "2.Much improved" on the CGI-I Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The change from baseline in Personal and Social Performance Scale (PSP) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The PSP scale measures the degree of disability the patient expresses in four domains of behavior: socially useful activities, personal and social relationships; self-care, and disturbing and aggressive behaviors. It is a 100-point rating scale, subdivided into 10 equal intervals to define the degree of disability. The patients with 71~100 points show mild difficulty and the patients with ≤ 30 points function so poorly that they require active care.
  • Drug Attitude Inventory (DAI-10) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Drug Attitude Inventory is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia patients. Respondents must indicate 'true' or 'false' for each item.
Not Provided
Not Provided
 
A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
An Open Label, Prospective, Non-Comparative Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Subjects With Schizophrenia

The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) Scale. Participants' safety will also be monitored throughout the study.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: Paliperidone ER
Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.
Experimental: Paliperidone Extended Release (ER)
Intervention: Drug: Paliperidone ER
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
353
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants who are diagnosed with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders [Edition 4] criteria)
  • Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
  • Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
  • Participants who are capable of and willing to fill out the questionnaire for themselves
  • Participants who are compliant with self-medication or can receive consistent help or support

Exclusion Criteria:

  • Participants with the past 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 allergy or hypersensitivity to risperidone or paliperidone
  • Participants who have taken clozapine, or have been exposed to the study drug within one month before screening
  • Participants who have been treated with the long acting antipsychotic injection within 28 days
  • Participants with significant risk including suicide or aggressive behavior
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01577160
CR015664, R076477SCH4034, PAL-TWN-MA2
No
Johnson & Johnson Taiwan Ltd
Johnson & Johnson Taiwan Ltd
Not Provided
Study Director: Johnson & Johnson Taiwan Ltd Clinical Trial Johnson & Johnson Taiwan Ltd
Johnson & Johnson Taiwan Ltd
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP