SchizophreniaHOSPIPalmNCT01926912
A Study of Usage of Paliperidone Palmitate in Patients With Schizophrenia in a Hospital Setting
An observational study of Schizophrenia, run by Janssen-Cilag International NV at 39 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 371 participants
- Where
- 39 sitesin 8 countries
- Study dates
- May 2013to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with schizophrenia receiving paliperidone palmitate in the hospital setting
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
39 sites in 8 countries.
39 sites in 8 countries
Germany9 sites
Study site
Berlin
Study site
Chemnitz
Study site
Dresden
Study site
Greifswald
Study site
Hamburg
Study site
Hennigsdorf
Study site
Neuruppin
Study site
Pfaffenhofen
Study site
Sachsen
Russia8 sites
Study site
Chelyabinsk
Study site
Moscow
Study site
Nizhny Novgorod
Study site
Omsk
Study site
Orenburg, Staritsa Village
Study site
Saint Petersburg
Study site
Tula Region
Study site
Yaroslavl
Bulgaria6 sites
Study site
Pazardzhik
Study site
Rousse
Study site
Sofia
Study site
Stara Zagora
Study site
Targovishte
Study site
Vratsa
Kazakhstan5 sites
Study site
Almaty
Study site
Astana
Study site
Kyzylorda
Study site
Taraz
Study site
Ust-Kamenogorsk
Greece4 sites
Study site
Heraklion Crete
Study site
Ioannina
Study site
Katerini Pieria
Study site
Thessaloniki
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- No intervention
- Keywords
- Schizophrenia, Paliperidone Palmitate, Hospital setting, Schizophrenic Disorders
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with schizophrenia | Not described Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 6 weeks
Number of participants who discontinue the study due to adverse events
Measured: Up to 6 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6
Change from baseline in body weight
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926912
- Sponsor's protocol ID
- CR100862
- Other IDs
- R092670SCH4017
- Acronym
- HOSPIPalm
- Status last verified
- Aug 2015
- First submitted
- 19 Aug 2013
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional Study
- ClinicalTrials.gov ID
- NCT01926912
- Acronym / sponsor ID
- HOSPIPalm / CR100862
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone Palmitate, Hospital setting, Schizophrenic Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with schizophrenia | – | Drug: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with schizophrenia receiving paliperidone palmitate in the hospital setting
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis 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. | Drug | Participants with schizophrenia |
Primary outcome
Number of participants with adverse events
Time frame: Up to 6 weeks
Number of participants who discontinue the study due to adverse events
Time frame: Up to 6 weeks
8 secondary outcomes
Change from baseline in Extrapyramidal Symptom Rating Scale (ESRS) score
Time frame: Baseline, Week 1, Week 2, Week 5, and Week 6
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
Clinical Global Impression - Severity (CGI-S) scale score
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Clinical Global Impression - Change (CGI-C) scale score
Time frame: Week 6
Change from baseline in Personal and Psychosocial functioning (PSP) scale score
Time frame: Baseline and Week 6
Subject Satisfaction with previous antipsychotic medication (MSQ) scale score
Time frame: Baseline
Subject Satisfaction with study medication (paliperidone palmitate) scale score
Time frame: Week 6
Change from baseline in body weight
Time frame: Baseline and Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
- HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
39 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen-Cilag International NV at 39 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany, Russia, Bulgaria, Kazakhstan, Greece and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.