Patient views on paliperidone palmitate 3-monthly: a cross-sectional questionnaire in UK community mental health teams

Abstract

Background:

Naturalistic studies examining paliperidone palmitate 3-monthly (PP3M) long-acting injection have proven PP3M to be a safe and effective maintenance treatment for patients with schizophrenia.

Objectives:

The aim of this study is to explore patients’ views and experiences with PP3M.

Design:

This was a cross-sectional, non-interventional, one-time questionnaire which was designed by pharmacists in collaboration with clinicians experienced in the use of long-acting antipsychotic injections.

Methods:

Eligible patients were adults currently prescribed PP3M who were attending their routine long-acting injection administration appointment at their community mental health team (CMHT).

Results:

Of 172 patients who were due PP3M during the study period, 68 (39.5%) completed the questionnaire. Of these, 31.3% found PP3M extremely helpful, 43.3% found it very helpful, 17.9% somewhat helpful, 3% slightly helpful and 4.5% not helpful at all. The majority of respondents (83.8%) preferred PP3M over PP1M, with convenience being cited as the main reason for preference (62.9%). The majority reported mild (35.4%) or no injection pain (30.8%) and no new side effects on PP3M (80.6%). For those experiencing side effects, they were largely not considered troubling (24.6%). CMHT contact remained unchanged since switching to PP3M (56.9%). In-person appointments were considered important (33.8%) or very important (35.4%). Most patients either had no preference (40.3%) or were opposed to having a monthly appointment (32.3%). When asked about preferred injection frequency, patients overwhelmingly selected the 3-monthly (62.5%) or 6-monthly option (35.9%).

Conclusion:

Patients generally reported high levels of satisfaction with PP3M and perceived the treatment to be helpful and well-tolerated, with most expressing a preference for PP3M compared with a 1-monthly injection.

Plain language summary

Patient views on paliperidone palmitate 3-monthly injection

People living with schizophrenia often need long-term medication to stay well. Some medicines are available as long-acting injections that are given monthly or every few months. Paliperidone palmitate 3- monthly (PP3M) is an injection given once every three months. This means patients need four injections per year. Whilst studies have shown that PP3M is an effective and convenient treatment for many people, little is known about how patients themselves feel about it. This study has asked patients in community mental health teams across South London to share their views and experience of PP3M. A short questionnaire was completed by 68 patients who were receiving PP3M as part of their usual care. Questions covered helpfulness of treatment, side effects, pain at the injection site, contact with healthcare staff and preferred injection frequency. Most patients said that PP3M was very or extremely helpful and that they preferred it over their previous monthly injection. Convenience was the most common reason for preferring PP3M. The majority reported mild or no injection pain and no new side effects. Contact with their community mental health team generally stayed the same after switching to PP3M. Seeing their team in person was considered important, and most preferred their injection frequency to remain every three months followed by every six months. Overall, this study suggests that patients find PP3M convenient, well-tolerated and acceptable in routine clinical practice. Understanding patient views is important to ensure that treatment plans both support effectiveness of treatment and patient quality of life.

Keywords

long-acting antipsychotic injection paliperidone 3-month psychosis questionnaire schizophrenia

Introduction

Paliperidone palmitate 3-monthly (PP3M) long-acting injection was designed to be given as a maintenance treatment to patients with a schizophrenia diagnosis who have previously been stabilised with 1-monthly paliperidone (PP1M). Its efficacy, safety, high retention and low relapse rates have been demonstrated in randomised controlled trials^1,2 and in naturalistic studies.^3
–6

Recent real-world studies from our hospital have revealed favourable long-term outcomes for patients treated with PP3M – over half of the patients were still on treatment at 3 years, the overall relapse rate was 5% and no relapses occurred beyond 18 months of follow-up.^7,8 While these positive results demonstrate that PP3M is an effective treatment option, treatment continuation alone does not capture how patients view their medication. Currently, there is a dearth of studies examining patients’ views on antipsychotic medication. Patient perspectives and attitudes play an important role in improving treatment effectiveness and medication compliance, but the full impact of these factors is not completely understood.⁹

In this cross-sectional questionnaire study, we aimed to explore how patients prescribed PP3M experience their treatment to better understand the general acceptability of PP3M and whether patient views align with the positive clinical outcomes previously reported.

Methods

Questionnaire design

This study was approved as a service improvement project by the Trust’s Drug and Therapeutics Committee (DTC code: DTC/2024/81) and the Service Users and Carer Involvement Lead. Data were collected between July 2024 and March 2025 at South London and Maudsley NHS Foundation Trust. The questionnaire was developed specifically for this project by pharmacists in collaboration with clinicians experienced in the use of long-acting antipsychotic injections. The content was informed by clinical experience and includes areas that have been identified as clinically relevant to patient experience with PP3M based on routine clinical practice. It was a cross-sectional, non-interventional, one-time questionnaire comprising ten items, of which eight were categorical (using Likert-type scales) and two were open-ended questions. The open-ended responses were reviewed and grouped into thematic categories. Frequencies of each category were reported descriptively. Patients were asked to share their views on the helpfulness of PP3M, preference between PP3M and PP1M, injection site pain, side effects, contact with their community mental health team (CMHT) and the preferred frequency of long-acting injection (LAI) administration.

Eligibility

CMHTs from four London boroughs (Croydon, Lambeth, Lewisham and Southwark) took part in the project. Eligible patients were adults currently prescribed PP3M who were attending their routine LAI administration appointment at their CMHT (Figure 1). To preserve patient anonymity and to ensure that the answers to the questionnaire did not interfere with patient’s treatment plan, no identifiable information was recorded including diagnosis, demographics or any details of their antipsychotic treatment. Patients did not receive any incentive or reimbursement for completing the questionnaire. Patient consent was assumed if the patient agreed to complete the questionnaire.

Figure 1.

Eligibility criteria.

Statistical analysis

Analysis was conducted using IBM SPSS Statistics (version 29.0.2.0) IBM Corporation, New York, US. Descriptive statistics (frequencies, median, mode) were used for categorical questions. Associations between questions were examined using non-parametric tests. Spearman’s rank-order correlation was applied to assess associations between categorical questions. For question pairs that showed significant association, chi-square tests of independence were performed. Fisher’s exact test was used where expected cell counts were small. For statistically significant associations, effect sizes were calculated using Cramer’s V. Statistical significance was set at p < 0.05 (Supplemental Material).

Reporting guidelines

STROBE guidelines were consulted to report on the outcomes.¹⁰

Results

Of 172 patients who were due their PP3M depot during the data collection period, 68 patients (39.5%) completed the questionnaire. While not all patients answered every question, the majority provided complete responses.

Helpfulness of PP3M injections, preference between 1M and 3M and reasons for preference

Most patients found PP3M helpful, with three in four patients rating it as ‘very helpful’ or ‘extremely helpful’ (Table 1). When patients were asked if they preferred PP3M or PP1M, almost all preferred PP3M, although a small number had no preference, and two patients preferred PP1M (Table 1). Question 3 was an open-ended question inviting patients to give a reason for their choice in question 2. Convenience was the most cited reason for preferring PP3M over PP1M, followed by medication efficacy and reduced injection pain/phobia. A small number of patients expressed no preference between the two LAI options (Table 1). Two responses were excluded from the analysis as they did not fit into any of the predefined categories.

Table 1.

Helpfulness of PP3M injections, preference between 1M and 3M and reasons for preference.

Question	Response	Percentage (%) (n = 67)
Overall, how helpful has the 3-monthly injection been for you?	Extremely helpful	31.3
	Very helpful	43.3
	Somewhat helpful	17.9
	Slightly helpful	3.0
	Not helpful at all	4.5
Completed responses = 67.
		% (n = 68)
How do you feel about the 3-monthly injection compared with the monthly?	I prefer the 3-monthly injection	83.8
	I have no preference	13.2
	I prefer the 1-monthly injection	2.9
Completed responses = 68.
		% (n = 35)
Reasons for selecting preference in previous question^a	Prefer PP3M – convenience	62.9
	Prefer PP3M – medication efficacy	22.9
	Prefer PP3M – injection pain/phobia	8.6
	No preference between PP1M and PP3M	5.7

Open-ended question.

PP1M, paliperidone palmitate 1-monthly; PP3M, paliperidone palmitate 3-monthly.

Injection site pain and adverse effects

When asked about pain at the injection site, the majority of patients reported experiencing some level of pain, with most patients rating the pain as mild or moderate. No patient experienced very severe injection site pain, less than 10% of patients rated the pain as severe and around one-third of patients reported no pain following PP3M administration (Table 2).

Table 2.

Adverse effects on PP3M.

Question	Response	Percentage (n = 65)
Do you experience injection pain when given a 3-monthly injection?	No	30.8
	Yes, mild pain	35.4
	Yes, moderate pain	24.6
	Yes, severe pain	9.2
	Yes, very severe pain	0
Completed responses = 65.
		% (n = 65)
From the following options, choose the one that best describes your experience of the side effects of the 3-monthly injection.	No side effects	60.0
	Some side effects, but they are not troubling	24.6
	Somewhat troubling side effects	10.8
	Very troubling side effects	0
	Unbearable side effects	4.6
Completed responses = 65.
		% (n = 62)
New side effects experienced since initiating the 3-monthly injection.	Yes	19.4
	No	80.6

PP3M, paliperidone palmitate 3-monthly.

Over half of the respondents reported not experiencing emergent adverse effects from PP3M. One in four experienced adverse effects but did not find them troubling, while a small proportion (15.4%) described experiencing somewhat troubling or unbearable adverse effects (Table 2). Most patients who reported adverse effects had already experienced them during treatment with PP1M. One in five patients reported new adverse effects that developed with PP3M. The newly emergent adverse effects are summarised in Table 3.

Table 3.

Reported adverse effects.

Adverse effects since starting PP3M*	Number of patients
Cramps	2
Dry mouth	2
Weight gain	2
Queasiness	2
Tiredness	2
Injection site reaction	2
Extrapyramidal side effects	2
Headaches	1
Hallucinations	1
Heart problem	1
Amenorrhoea	1

Some patients reported more than one adverse effect.

PP3M, paliperidone palmitate 3-monthly.

Contact with CMHT

When asked about the change in contact with their CMHT after switching to PP3M, over half of the patients reported no change, with around one-third of patients stating they were in contact more often. Only a small proportion reported less frequent contact (Table 4). Regarding the importance of in-person appointments, most patients felt that seeing their team in person was either important or very important. One in five patients were neutral, while less than 10% considered them unimportant or very unimportant (Table 4). Patients expressed mixed views regarding monthly routine appointments without injection administration. Just over one-quarter were in favour, with the majority reporting they were either neutral or against having monthly appointments (Table 4).

Table 4.

CMHT contact.

Question	Response	Percentage (n = 65)
How has your contact with your community mental health team changed since switching to a 3-monthly injection?	I am in contact more often	30.8
	There has been no change	56.9
	I am in contact less often	12.3
Completed responses = 65.
		% (n = 65)
How important is it for you to see your community mental health team in person?	Very important	35.4
	Important	33.8
	Neither important nor unimportant	21.5
	Unimportant	3.1
	Very unimportant	6.2
Completed responses = 65.
		% (n = 62)
Would you prefer to have a monthly appointment with healthcare staff even if you do not receive an injection?	I would prefer to have a monthly appointment	27.4
	Neither prefer nor against having a monthly appointment	40.3
	I would be against having a monthly appointment	32.3
Completed responses = 62.

CMHT, community mental health team.

Preferred frequency of LAI administration

Almost all patients preferred less frequent injection schedules. Approximately two-thirds preferred PP3M while one-third preferred PP6M. Only one patient preferred PP1M (Table 5).

Table 5.

Preferred frequency of LAI administration.

If you could choose one option, how often would you like to have your antipsychotic injection?*
	Percentage (n = 64)
Every week	0
Every 2 weeks	0
Once a month	1.6
Once every 3 months	62.5
Once every 6 months	35.9

Completed responses = 64.

LAI, long-acting injection.

Discussion

The majority of patients who participated in the questionnaire found PP3M helpful and preferred PP3M to PP1M. Most patients reported favouring PP3M primarily because of convenience and, to a lesser extent, because of improved perceived medication efficacy and reduced injection burden. Similar findings were reported in cross-sectional surveys and post-hoc analysis from the UK, US and the Netherlands – patients expressed high satisfaction levels with PP3M after changing from PP1M^11
–13 and cited convenience as the main advantage.^11,13

Adverse effects

In our study, the majority of patients experienced mild or moderate pain at the injection site. Severe injection pain was uncommon (<10%) and around a third of patients reported no pain at all. Over half of the patients said they had no adverse effects with PP3M. In fact, the perceived helpfulness of PP3M appeared to be influenced by the tolerability. The patients in our cohort who reported no adverse effects with PP3M also tended to perceive PP3M as more helpful (p < 0.005). For those who experienced adverse effects, these were either not troubling or were only somewhat troubling. When injection site pain was rated as more severe by the patient, they were significantly more likely to rate the overall adverse effect profile of PP3M as more troubling (p < 0.001).

In total, over four-fifths of respondents did not perceive any new adverse effects since switching to PP3M. The most commonly reported emergent adverse effects included weight gain, tiredness, EPSEs and cramps. Similar patient views were reported in a Dutch study, where patients had the same or fewer adverse effects with PP3M compared with PP1M.¹² The most common effects reported were weight gain and EPSEs.¹²

CMHT contact

Changing from monthly to 3-monthly injection appointments did not affect the frequency of contact with CMHTs for the majority of patients. In fact, around a third of patients perceived that their contact with their CMHTs had increased after switching to PP3M. These findings are consistent with a Nordic study, where the frequency and the content of clinical contact remained unchanged after the switch to PP3M.¹⁴ Importantly, patients in that study described how they were able to focus more on their recovery and less on their diagnosis¹⁴ as a result of reduced contact with services. In contrast, in the Dutch study, around half of the participants reported no change in contact frequency, and the remainder reported reduced contact.¹² In our study, we found that those patients who found PP3M helpful also reported increased contact with their teams. Most patients preferred to see their CMHT in person rather than online, and just over a quarter were in favour of monthly appointments (preferably in person). The majority were either neutral or against monthly appointments.

Administration frequency

Patients were overwhelmingly in favour of VLAIs. Two-thirds of respondents preferred their current frequency (3-monthly), one-third preferred a 6-monthly interval, whilst only one patient preferred monthly injections. Neither weekly nor 2-weekly options were selected by any patient.

As mentioned, convenience seems to be a key factor for selecting PP3M. Patients described their preference for PP3M stating: ‘It allows me to do other things. I don’t have to be going to the clinic to take the injection’, ‘It is convenient for my work’ and ‘Because it saves money for travel and makes me feel better’. Less frequent administration helps not only to maintain symptom control, but also to support patients to reach personal goals, improve social relationships, find employment and shift focus away from their mental health diagnosis towards leading more independent and fulfilling lives.¹⁵ Continued contact with mental health services, even with less frequent injection appointments, remains an important part of their recovery journey.

This study adds to the growing literature on patient acceptability and satisfaction with PP3M by providing data from an independent NHS cohort using a service-based design across high- and low-intensity mental health community teams. Our findings are consistent with previous studies, which have reported that patients value the convenience of long-acting formulations,¹¹ and a reduced injection frequency whilst retaining the same contact with mental health services.¹⁴

Limitations

This study has several limitations. Firstly, baseline characteristics were not collected including age, sex, diagnosis, duration of psychiatric illness or duration of PP3M treatment or PP1M treatment. This was to maintain anonymity and allow patients to freely express their views without concerns that their responses might influence their treatment. However, the absence of these variables and comparator data (i.e. views of PP1M and PP6M users) limits the ability to contextualise the sample and prevents subgroup analyses. Secondly, the questionnaire was administered at a single time point. Longitudinal studies examining patient views before and after transitioning to PP3M would provide more insight into potential changes in views over time. Thirdly, the questionnaire was offered to patients receiving PP3M treatment in the community, which may introduce selection bias, as their views may differ from those who had already discontinued PP3M or those who refused to complete the questionnaire.^16,17 Fourthly, the questionnaire was offered to patient during their routine depot appointments, often in close proximity to healthcare staff which may introduce social desirability bias. Fifthly, participating community mental health teams included services providing both high- and low-intensity levels of patient care to capture a range of patients receiving PP3M in routine practice. However, operational procedures may vary across teams; that is, some eligible patients may not have been approached because of operational factors, staff awareness or appointment logistics. Additionally, some patients may have declined to participate. These factors introduce the possibility of non-response bias, limiting generalisability. Finally, site of depot administration, timing of the injection and administration techniques may vary between teams and could influence patient-reported side effects. This was not captured in the questionnaire and was therefore not included in the analysis.

Summary

Most patients found PP3M very helpful and preferred it over PP1M. The majority reported mild or no injection pain and no emergent side effects, and even where side effects did occur, they were largely not considered troubling. CMHT contact remained unchanged since switching to PP3M for the majority of patients. In-person appointments were considered important or very important by most respondents. Most patients either had no preference or were opposed to having a monthly appointment. Finally, when asked about preferred injection frequency, patients overwhelmingly selected 3 or 6 monthly.

Supplemental Material

sj-docx-1-tpp-10.1177_20451253261450788 – Supplemental material for Patient views on paliperidone palmitate 3-monthly: a cross-sectional questionnaire in UK community mental health teams

Supplemental material, sj-docx-1-tpp-10.1177_20451253261450788 for Patient views on paliperidone palmitate 3-monthly: a cross-sectional questionnaire in UK community mental health teams by Ivana Clark, Siobhan Gee and David Taylor in Therapeutic Advances in Psychopharmacology

Supplemental Material

sj-docx-2-tpp-10.1177_20451253261450788 – Supplemental material for Patient views on paliperidone palmitate 3-monthly: a cross-sectional questionnaire in UK community mental health teams

Supplemental material, sj-docx-2-tpp-10.1177_20451253261450788 for Patient views on paliperidone palmitate 3-monthly: a cross-sectional questionnaire in UK community mental health teams by Ivana Clark, Siobhan Gee and David Taylor in Therapeutic Advances in Psychopharmacology

Footnotes

Acknowledgements

The authors would like to thank all participating community mental health teams and pharmacy staff who supported the dissemination of the questionnaire.

Declarations

ORCID iDs

Ivana Clark

Siobhan Gee

David Taylor

Supplemental material

Supplemental material for this article is available online.

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Supplementary Material

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