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

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ClinicalTrials.gov Identifier: NCT01577160
Recruitment Status : Completed
First Posted : April 13, 2012
Results First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Paliperidone ER Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Prospective, Non-Comparative Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Subjects With Schizophrenia
Study Start Date : May 2008
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Paliperidone Extended Release (ER) 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.



Primary Outcome Measures :
  1. Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale [ Time Frame: Week 12 ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12 [ Time Frame: Baseline, Week 12 ]
    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.

  2. Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: Week 12 ]
    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.

  3. Change From Baseline in Personal and Social Performance (PSP) Score at Week 12 [ Time Frame: Baseline, Week 12 ]
    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).

  4. Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12 [ Time Frame: Baseline, Week 12 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577160


Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan Ltd Clinical Trial Johnson & Johnson Taiwan Ltd

Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT01577160     History of Changes
Other Study ID Numbers: CR015664
R076477SCH4034 ( Other Identifier: Johnson & Johnson Taiwan Ltd )
PAL-TWN-MA2 ( Other Identifier: Johnson & Johnson Taiwan Ltd )
First Posted: April 13, 2012    Key Record Dates
Results First Posted: January 14, 2014
Last Update Posted: January 14, 2014
Last Verified: November 2013

Keywords provided by Johnson & Johnson Taiwan Ltd:
Schizophrenia
Paliperidone Extended Release (ER)

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents