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A Study of Usage of Paliperidone Palmitate in Patients With Schizophrenia in a Hospital Setting (HOSPIPalm)

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ClinicalTrials.gov Identifier: NCT01926912
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Brief Summary:
The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate use and pattern of paliperidone palmitate usage in participants with schizophrenia in the hospital setting.

Condition or disease Intervention/treatment
Schizophrenia Drug: No intervention

Detailed Description:
This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), multicenter, observational study (a type of study in which participants are observed or certain outcomes are measured). This study will consist of 6-week observational period during which data will be collected for participants who are hospitalized due to schizophrenia exacerbation and are receiving treatment with paliperidone palmitate (treatment initiated within 3 weeks after admission to hospital). The participant satisfaction will be evaluated at week 6 (or early discontinuation). Safety evaluations will include body weight, extrapyramidal symptom (eg, inability to initiate movement and inability to remain motionless) rating scale scores, concomitant therapy and assessment of adverse events.

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Study Type : Observational
Actual Enrollment : 371 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional Study
Study Start Date : May 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants with schizophrenia Drug: No intervention
This is an observational study. Participants prescribed with paliperidone palmitate by the treating physician as per local labeling information in the hospital setting will be observed and data will be collected.




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Up to 6 weeks ]
  2. Number of participants who discontinue the study due to adverse events [ Time Frame: Up to 6 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Extrapyramidal Symptom Rating Scale (ESRS) score [ Time Frame: Baseline, Week 1, Week 2, Week 5, and Week 6 ]
    The ESRS is a 12 item clinician-rated scale designed to assess the severety of extrapyramidal symptoms. Dyskinesic movements are rated according to bothfrequency and amplitude. It measures the four types of drug-induced movement disorders. (Parkinsonism, Dystonia, akathisia, and Dyskinesia). Items are rated on a 7-point scale ranging from 0 (normal) to 6 (extremely severe). The higher the score, the more severely the symptoms affect function. Higher scores indicate worsening.

  2. Change from baseline in total Brief Psychiatric Rating Scale (BPRS) score [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6 ]
    The BPRS is used for the measurement of psychiatric symptoms. The BPRS is an 18 item questionnaire and each question is rated on a 7 point scale ranging from 1 (not present) to 7 (extremely severe). The total score for the 18 question will be calculated by adding score of each question. The interpretation of the total scores are: 0-9 will indicate "not a schizoaffective case"; 10-20 will indicate "possible schizoaffective case"; and 21 or more, will indicate "evident schizoaffective case". Higher scores indicate worsening.

  3. Clinical Global Impression - Severity (CGI-S) scale score [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6 ]
    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.

  4. Clinical Global Impression - Change (CGI-C) scale score [ Time Frame: Week 6 ]
    The CGI-C is a 7-point assessment scale of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.

  5. Change from baseline in Personal and Psychosocial functioning (PSP) scale score [ Time Frame: Baseline and Week 6 ]
    The PSP is used as a measure of personal and social functioning of participants with psychiatric disorders. The PSP scale assesses the degree of difficulty a participant 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 and provide rating from 1 to 100. Participants with score of 71 to 100 have a mild degree of difficulty; from 31 to 70 have marked difficulty and from 1 to 30, have represent severe degrees of difficulty. Lower scores indicate worsening.

  6. Subject Satisfaction with previous antipsychotic medication (MSQ) scale score [ Time Frame: Baseline ]
    Treatment satisfaction with previous anti psychiatric medication among participants with schizophrenia will be assessed by using the MSQ scale. It consists of 1 question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied. Lower scores indicate worsening.

  7. Subject Satisfaction with study medication (paliperidone palmitate) scale score [ Time Frame: Week 6 ]
    Treatment satisfaction with study medication (paliperidone palmitate) among participants with schizophrenia will be assessed by using the MSQ scale. It consists of 1 question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied. Lower scores indicate worsening.

  8. Change from baseline in body weight [ Time Frame: Baseline and Week 6 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with schizophrenia receiving paliperidone palmitate in the hospital setting
Criteria

Inclusion Criteria:

  • Participants diagnosed with schizophrenia
  • Participant admitted to hospital due to an exacerbation of their schizophrenia prior to any study-related activity
  • Participant may, in the opinion of the participating physician, benefit from treatment with paliperidone palmitate which will be initiated within 3 weeks after admission to hospital

Exclusion Criteria:

  • Participant has a known hypersensitivity to paliperidone or risperidone
  • Participant has previously been treated with paliperidone palmitate
  • Participant has a history of neuroleptic malignant syndrome
  • Participant was on clozapine or has previously been treated with any long-acting injectable antipsychotic during the last 3 months

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): NCT01926912


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Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV

Additional Information:
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Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01926912     History of Changes
Other Study ID Numbers: CR100862
R092670SCH4017 ( Other Identifier: Janssen-Cilag International NV )
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Janssen-Cilag International NV:
Schizophrenia
Paliperidone Palmitate
Hospital setting
Schizophrenic Disorders

Additional relevant MeSH terms:
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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