SchizophreniaNCT03809325
A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
An observational study of Schizophrenia, run by Janssen-Cilag International NV at 41 sites in 7 countries.
Trial summary
The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone Palmitate 3-Month Formulation (PP3M)
- Type of treatment
- Injection or infusion
- How many people
- 225 participants
- Where
- 41 sitesin 7 countries
- Study dates
- 21 Nov 2018to 12 Jul 2019
- 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 diagnosed with schizophrenia who are currently receiving paliperidone palmitate 3-month formulation (PP3M) and have previously received 4 to 6 injections of PP3M treatment will be enrolled. Feedback will be collected using an online questionnaire-based tool at a single data collection time point.
Who may be able to join
- Have a diagnosis of schizophrenia (according to International Classification of Diseases [ICD]-10)
- Be currently receiving PP3M and have previously received 4 to 6 injections of PP3M
- Have the required language skills to participate in the online questionnaire, in the opinion of the physician
- Be able and willing to provide their informed consent for study participation
Who cannot join
- Has received involuntary treatment with PP3M
- Was switched to PP3M treatment within a clinical trial
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
Spain13 sites
Hosp. Abente E Lago
A Coruña, 15006
Csm Miraflores
Alcobendas, 28100
Csm Arganda Del Rey
Arganda, 28500
Usmc Carmona
Carmona, 41410
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28009
Usmc Mairena Del Aljarafe
Mairena del Aljarafe, 41927
Centre Hosp. de Manresa
Manresa, 8243
Corporacio Sanitari Parc Tauli
Sabadell, 8208
Hosp. Univ. de Torrevieja
Torrevieja, 3188
Hosp. Clinico Univ. de Valencia
Valencia, 46010
Csm Rondilla
Valladolid, 47010
Hosp. Psiquiatrico Alava
Vitoria-Gasteiz, 1006
Hosp. Univ. Miguel Servet
Zaragoza, 50009
France11 sites
Centre Médico Psychologique De Courbevoie
Asnières-sur-Seine, 92600
Centre Medico Psychologique
Cagnes-sur-Mer, 6800
Cabinet medical
Dax, 40100
Centre Hospitalier Esquirol
Limoges, 87025
CH de Jury
Metz, 57073
CH Montauban
Montauban, 82013
Hopital la Colombiere
Montpellier, 34090
Centre Medico Psychologique Le Rembrandt
Nice, 6300
Centre Hospitalier de Novillars
Novillars, 25220
Centre Hospitalier Guillaume Regnier
Rennes, 35703
Hopital Sainte Musse
Toulon, 83100
Italy6 sites
Azienda Sanitaria Alto Adige
Bolzano, 39100
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, 25100
CSM Frosinone
Frosinone, 3100
Casa di Cura Villa Von Siebenthal
Genzano di Roma, 100045
Centro Igiene Mentale ASL Salerno
Oliveto Citra, 84020
SPDC Asltaranto
Statte, 74010
Hungary4 sites
Toldy Ferenc Kórház-Rendelőintézet
Cegléd, 2700
Kemenesaljai Egyesített Kórház-Szakorvosi Rendelointézet
Celldömölk, 9500
Sántha Kálmán Szakkórház
Nagykálló, 4320
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100
Germany3 sites
Vivantes Klinikum Am Urban
Berlin, 10967
NPZR - Neuropsychatrisches Zentrum Riem
München, 81829
Kbo-Inn-Salzach-Klinikum GmbH
Wasserburg A. Inn, 83512
United Kingdom3 sites
Birmingham & Solihull MH NHS FT
Birmingham, B18 5SD
Leicester Partnership NHS Trust
Leicester, LE2 0TA
West London Mental Health Trust
London, W3 8NJ
About this study
Official title: Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone Palmitate 3-Month Formulation (PP3M)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone Palmitate 3-Month Formulation (PP3M)Drug
Also called Trevicta
No intervention will be administered as a part of this study. Participants who have been treated with PP3M in clinical practice will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Schizophrenia | No intervention will be administered as a part of this study. Participants diagnosed with schizophrenia, who have been treated with 4 to 6 injections of paliperidone palmitate 3-month formulation (PP3M), together with the corresponding physician, and the corresponding nurse and carer where applicable for each participant will be enrolled in this survey. The data source for this study will be the online questionnaire used for each participant, physician, and the corresponding nurse and carer where applicable. Receives: Drug: Paliperidone Palmitate 3-Month Formulation (PP3M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's Experience with PP3M Treatment
Participant's experience with paliperidone palmitate 3-month formulation (PP3M) treatment will be evaluated qualitatively through an online questionnaire. Each questionnaire will include a total of approximately 30 to 35 multiple choice questions related to following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.
Measured: 1 day
Secondary outcomes (4)
Responses to the Questionnaires
The response to the questionnaires of the corresponding physician, and the corresponding nurse and carer where applicable, for each participant will be collected for the following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.
Measured: 1 day
Clinical Global Impression-Severity (CGI-S) Score
The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
Measured: 1 day
Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)
The PANSS is a validated scale specific for the measurement of the symptoms of schizophrenia. The neuropsychiatric symptoms of schizophrenia are assessed across 3 subscales comprising a total of 30 items; the positive [P] and negative [N] subscales each includes 7 items, while the general psychopathology [G] subscale includes 16 items. Lack of judgment and insight's score is 12th item of the general psychopathology subscale (G12 item) of PANSS with score ranges from 1 to 7. Higher scores indicate worsening.
Measured: 1 day
European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score
EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The responses to the 5 dimensions are used to compute a single utility score ranging from zero (worst health state) to 1 (better health state) representing the general health status of the individual.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start21 Nov 2018
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
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
- Cross-sectional
- Enrolment
- 225 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
- NCT03809325
- Sponsor's protocol ID
- CR108568
- Other IDs
- R092670SCH4066
- Status last verified
- Apr 2025
- First submitted
- 17 Jan 2019
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
- ClinicalTrials.gov ID
- NCT03809325
- Acronym / sponsor ID
- CR108568
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 18 Jan 2019 (actual)
- 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 is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Schizophrenia | – | Drug: Paliperidone Palmitate 3-Month Formulation (PP3M)No intervention will be administered as a part of this study. Participants diagnosed with schizophrenia, who have been treated with 4 to 6 injections of paliperidone palmitate 3-month formulation (PP3M), together with the corresponding physician, and the corresponding nurse and carer where applicable for each participant will be enrolled in this survey. The data source for this study will be the online questionnaire used for each participant, physician, and the corresponding nurse and carer where applicable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with schizophrenia who are currently receiving paliperidone palmitate 3-month formulation (PP3M) and have previously received 4 to 6 injections of PP3M treatment will be enrolled. Feedback will be collected using an online questionnaire-based tool at a single data collection time point.
Key inclusion criteria (4 listed)
- Have a diagnosis of schizophrenia (according to International Classification of Diseases [ICD]-10)
- Be currently receiving PP3M and have previously received 4 to 6 injections of PP3M
- Have the required language skills to participate in the online questionnaire, in the opinion of the physician
- Be able and willing to provide their informed consent for study participation
Key exclusion criteria (2 listed)
- Has received involuntary treatment with PP3M
- Was switched to PP3M treatment within a clinical trial
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 |
|---|---|---|
| Paliperidone Palmitate 3-Month Formulation (PP3M)Also: TrevictaNo intervention will be administered as a part of this study. Participants who have been treated with PP3M in clinical practice will be enrolled. | Drug | Participants with Schizophrenia |
Primary outcome
Participant's Experience with PP3M Treatment
Time frame: 1 day
Participant's experience with paliperidone palmitate 3-month formulation (PP3M) treatment will be evaluated qualitatively through an online questionnaire. Each questionnaire will include a total of approximately 30 to 35 multiple choice questions related to following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.
4 secondary outcomes
Responses to the Questionnaires
Time frame: 1 day
Clinical Global Impression-Severity (CGI-S) Score
Time frame: 1 day
Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)
Time frame: 1 day
European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score
Time frame: 1 day
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 27 Apr 2025.
- Individual participant dataSharing planned: No
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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
41 sites in 7 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 41 sites in 7 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 4 inclusion and 2 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Spain, France, Italy, Hungary, Germany and 2 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?
Participant's Experience with PP3M Treatment (time frame: 1 day). 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 27 Apr 2025.