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

HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional Study

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 371

Contacts and Locations

Study Locations

• Belgium
  • Diest, Belgium
  • Saint-Servais, Belgium
  • Tournai, Belgium
• Bulgaria
  • Pazardjik, Bulgaria
  • Rousse, Bulgaria
  • Sofia, Bulgaria
  • Stara Zagora, Bulgaria
  • Targovishte, Bulgaria
  • Vratsa, Bulgaria
• Denmark
  • Helsingør, Denmark
  • Kobenhavn S, Denmark
• Germany
  • Berlin, Germany
  • Chemnitz, Germany
  • Dresden, Germany
  • Greifswald, Germany
  • Hamburg, Germany
  • Hennigsdorf, Germany
  • Neuruppin, Germany
  • Pfaffenhofen, Germany
  • Sachsen, Germany
• Greece
  • Heraklion Crete, Greece
  • Ioannina, Greece
  • Katerini Pieria, Greece
  • Thessaloniki, Greece
• Israel
  • Bat-Yam, Israel
  • Tel Hashomer, Israel
• Kazakhstan
  • Almaty, Kazakhstan
  • Astana, Kazakhstan
  • Kyzylorda, Kazakhstan
  • Taraz, Kazakhstan
  • Ust-Kamenogorsk, Kazakhstan
• Russian Federation
  • Chelyabinsk, Russian Federation
  • Moscow, Russian Federation
  • Nizhniy Novgorod, Russian Federation
  • Omsk, Russian Federation
  • Orenburg, Staritsa Village, Russian Federation
  • Saint-Petersburg, Russian Federation
  • Tula Region, Russian Federation
  • Yaroslavl, Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with schizophrenia receiving paliperidone palmitate in the hospital setting

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	Up to 6 weeks
Number of participants who discontinue the study due to adverse events	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Extrapyramidal Symptom Rating Scale (ESRS) score	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.	Baseline, Week 1, Week 2, Week 5, and Week 6
Change from baseline in total Brief Psychiatric Rating Scale (BPRS) score	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.	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Clinical Global Impression - Severity (CGI-S) scale score	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.	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Clinical Global Impression - Change (CGI-C) scale score	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.	Week 6
Change from baseline in Personal and Psychosocial functioning (PSP) scale score	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.	Baseline and Week 6
Subject Satisfaction with previous antipsychotic medication (MSQ) scale score	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.	Baseline
Subject Satisfaction with study medication (paliperidone palmitate) scale score	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.	Week 6
Change from baseline in body weight		Baseline and Week 6

Collaborators and Investigators

• Sponsor: Janssen-Cilag International NV

Publications and helpful links

Helpful Links

• HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional Study

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (Estimate): August 21, 2013

Study Record Updates

• Last Update Posted (Estimate): August 24, 2015
• Last Update Submitted That Met QC Criteria: August 21, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Schizophrenia; Paliperidone Palmitate; Schizophrenic Disorders; Hospital setting
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CR100862; R092670SCH4017 (Other Identifier: Janssen-Cilag International NV)