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SchizophreniaPhase 4NCT03713658

A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities

A Phase 4 study testing Risperidone 3 mg, Paliperidone Palmitate 50 mg eq. and Paliperidone Palmitate 75 mg eq. in people with Schizophrenia, run by Janssen Research & Development, LLC at 3 sites in Rwanda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the feasibility of conducting a study of oral risperidone followed by paliperidone palmitate for once monthly (PP1M) and paliperidone palmitate for every 3 months (PP3M) in rwandan healthcare facilities with mental healthcare capabilities. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Schizophrenia
What is being tested?
Risperidone 3 mg, Paliperidone Palmitate 50 mg eq. and Paliperidone Palmitate 75 mg eq.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
3 sitesRwanda
Study dates
18 Oct 2018to 2 Dec 2019
Phase
Phase 4
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with diagnosis of schizophrenia by mini international neuropsychiatric interview (MINI)- Screen/ MINI (Module K) that requires treatment initiation or a change in treatment to better address safety or efficacy limitations of current treatment
  • Participants at least moderately ill as measured by the clinical global impressions - severity of schizophrenia (CGI-SS) scale for schizophrenia, or experiencing poorly tolerated side effects from their current medications, or having difficulty with adequate adherence to treatment, per the investigator's judgement
  • Participants have a primary caregiver who is willing to participate in this study (caregiver should be knowledgeable about the participant's condition and is expected to be with the participant for greater than (>) 24 hours each week for the duration of the study)
  • Participants able to give consent to participate in a clinical study that includes treatment with risperidone and long-acting injectable formulations of paliperidone palmitate. Participants must be willing to receive injections. The participant and the caregiver participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Participants must be willing and able to provide responses for all self-administered questionnaires

Who cannot join

  • Participants have a physical, mental, or legal incapacity that prevents a valid consent or capacity to complete about 12 months of treatment with antipsychotic medication and compliance with this study protocol
  • Participants with history of organic brain syndromes, comorbid psychiatric and/or physical illnesses, or significant comorbid substance abuse that is likely to interfere with understanding of or compliance with study requirements
  • Participants with known allergies, hypersensitivity, or intolerance to risperidone or paliperidone palmitate or their excipients
  • Participants with poor prior response to risperidone
  • Participants who received an investigational medication (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned first dose of study medication, or is currently enrolled in an investigational study

Trial locations and contacts

3 sites in 1 country.

Rwanda3 sites

  • CARAES Ndera Neuro-Psychiatric Hospital

    Kigali, 423

  • Ruhengeri Referral Hospital, Public Hospital

    Musanze District, 57

  • Kibungo Referral Hospital

    Ngoma District, 10

Other trials in Rwanda

About this study

Official title: A Pilot-Study in Rwandan Health Care Settings to Examine the Feasibility of a Large Pragmatic Clinical Study to Assess the Value of Paliperidone Palmitate in Rwanda

The purpose of this study is to evaluate the feasibility of conducting a study of oral risperidone followed by paliperidone palmitate for once monthly (PP1M) and paliperidone palmitate for every 3 months (PP3M) in rwandan healthcare facilities with mental healthcare capabilities.

Conditions
Schizophrenia
Being tested
Risperidone 3 mg, Paliperidone Palmitate 50 mg eq., Paliperidone Palmitate 75 mg eq., Paliperidone Palmitate 100 mg eq., Paliperidone Palmitate 150 mg eq.
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risperidone 3 mgDrug

    Participants will receive 3 mg oral risperidone tablets once daily for up to one Week.

  • Paliperidone Palmitate 50 mg eq.Drug

    Also called R092670

    Participants will receive 50 mg eq. PP1M intramuscular injection for 17 Weeks.

  • Paliperidone Palmitate 75 mg eq.Drug

    Also called R092670

    Participants will receive 75 mg eq. PP1M intramuscular injection for 17 Weeks.

  • Paliperidone Palmitate 100 mg eq.Drug

    Also called R092670

    Participants will receive 100 mg eq. PP1M intramuscular injection for 17 Weeks.

  • Paliperidone Palmitate 150 mg eq.Drug

    Also called R092670

    Participants will receive 150 mg eq. PP1M intramuscular injection for 17 Weeks.

  • Paliperidone Palmitate 175 mg eq.Drug

    Also called R092670

    Participants will receive 175 mg eq. PP3M intramuscular injection for 24 Weeks.

  • Paliperidone Palmitate 263 mg eq.Drug

    Also called R092670

    Participants will receive 263 mg eq. PP3M intramuscular injection for 24 Weeks.

  • Paliperidone Palmitate 350 mg eq.Drug

    Also called R092670

    Participants will receive 350 mg eq. PP3M intramuscular injection for 24 Weeks.

  • Paliperidone Palmitate 525 mg eq.Drug

    Also called R092670

    Participants will receive 525 mg eq. PP3M intramuscular injection for 24 Weeks.

Study groups in NCT03713658
Study groupRoleWhat they receive
Oral RisperidoneExperimentalParticipants will receive 3 milligram (mg) oral risperidone tablets once daily for up to one Week to determine tolerability based on investigator review.
Receives: Drug: Risperidone 3 mg
Paliperidone Palmitate Once Monthly (PP1M)ExperimentalParticipants will receive 50, 75, 100 or 150 mg eq. ([paliperidone palmitate] mg equivalent [to paliperidone]) long acting formulation of paliperidone palmitate once monthly (PP1M) intramuscular injection for 4 months (17 weeks) plus option to continue 3 more months if not stabilized depending on the participant's clinical safety, tolerability and efficacy requirements.
Receives: Drug: Paliperidone Palmitate 50 mg eq.; Drug: Paliperidone Palmitate 75 mg eq.; Drug: Paliperidone Palmitate 100 mg eq.; Drug: Paliperidone Palmitate 150 mg eq.
Paliperidone Palmitate Every 3 Months (PP3M)ExperimentalParticipants will receive 175, 263, 350 or 525 mg eq. ([paliperidone palmitate] mg equivalent [to paliperidone]) long acting formulation of paliperidone palmitate every 3 months (PP3M) intramuscular injection for 24 Weeks.
Receives: Drug: Paliperidone Palmitate 175 mg eq.; Drug: Paliperidone Palmitate 263 mg eq.; Drug: Paliperidone Palmitate 350 mg eq.; Drug: Paliperidone Palmitate 525 mg eq.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Successful Completion of Study Procedures

    Percentage of participants with successful completion of study procedures related to diagnosis and outcome measures assessment will be reported.

    Measured: Up to Week 46

  2. Percentage of Participants With Successful Delivery of Risperidone/PP1M/PP3M for the Duration of the Study

    Percentage of participants with successful delivery of risperidone/PP1M/PP3M for the duration of the study will be reported.

    Measured: Up to Week 46

  3. Percentage of Participants With Successful Administration of Risperidone/PP1M/PP3M Throughout the Study

    Percentage of participants with successful administration of risperidone/PP1M/PP3M throughout the study will be reported.

    Measured: Up to Week 46

  4. Quality of Life as Assessed by World Health Organization Quality of Life Scale Brief Version (WHO QoL-BREF) Total Score

    The WHO QoL-BREF is a 25 item scale used to assess the quality of life. All items are rated on a five-point likert scale using response categories such as 1 represents very poor and 5 represents very well with a possible maximum score of 125 and a minimum score of 25.

    Measured: Up to Week 46

  5. Clinician Satisfaction as Assessed by Clinician Satisfaction Rating Scale Score

    The Clinician Satisfaction Rating is a 4-item scale. Two items use a Likert scale with a six-point range from 0 (definitively not) to 6 (definitely) and two items are multiple-choice (example, "select all that apply"). The scale will be used to assess the acceptability and/or burden for the provider associated with the study including treatment with long-acting injectables (LAIs).

    Measured: Up to Week 46

Secondary outcomes (8)

  1. Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI)-MINI Screen and Module K Criteria

    The MINI-Screen is a structured and standardized diagnostic interview used to determine the most common psychiatric disorders according to axis I diagnostic and statistical manual of mental disorders-fourth edition text revision (DSM-IV-TR) and the international classification of diseases and related health problems (ICD-10). The MINI-screen will be administered to participants for preselection by a qualified psychiatric professional. If this step is passed, then Module K of MINI will be applied by a medical doctor (preferably a psychiatrist) or a psychologist in order to confirm the diagnosis of schizophrenia and to determine if there are other psychiatric conditions present. Number of participants who met MINI criteria will be assessed.

    Measured: Up to Week 46

  2. Number of Participants Intended to Complete/Attend Next Visit as Assessed by Intent-to-Attend (ITA) Plus Assessment Scale

    The ITA-Plus scale is a single Likert scale question with a range of 0 indicates definitely not attending to 6 indicates definitely attending that will be used to estimate the likelihood of completing the study or attending the next visit to provides qualitative feedback on why completion/attendance may not occur. Number of participants intended to complete/attend next visit will be assessed.

    Measured: Up to Week 46

  3. Direct Cost Assessment of Schizophrenia Care as Assessed by Client Service Receipt Inventory (CSRI) Scale Score

    The CSRI scale will be used to assess the costs of schizophrenia care for participants, caregivers, and health care providers, especially direct costs.

    Measured: Up to Week 46

  4. Indirect Cost Assessment of Schizophrenia Care as Assessed by Cost Assessment Questionnaire (CAQ)

    The CAQ will be used to assess the costs of schizophrenia care for participants, caregivers, and health care providers, especially indirect costs.

    Measured: Up to Week 46

  5. Change From Baseline in Sheehan Disability Scale (SDS) Total Score

    SDS will be used to assess the functioning of participants with schizophrenia. It has participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0 (no impairment) - 10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement.

    Measured: Baseline up to Week 46

  6. Number of Participants With Adverse Events (AEs) as a Measure of Safety

    Safety will be assessed by AEs along with concomitant medications, past medical history, and demographics of participants who will participate in this study. An adverse event is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the medication. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.

    Measured: Up to Week 46

  7. Psychosis as Assessed by Mental Illness With Lay Evidence (SMILE) Scale Score

    The Psychosis module of the SMILE will be used to assess the clinical symptoms of schizophrenia. It is a 15-item Likert scale covering questions to describe participants condition like if they have kept the body neat and clean, difficulty in completing routine tasks, talked to themselves etc with answers on a point range of 0 (Never) to 5 (All the time). It uses 7-day recall period. Both the participant and caregiver participant will complete this scale.

    Measured: Up to Week 46

  8. Clinical Global Impression - Severity of Schizophrenia (CGI-SS) Scale Total Score

    The CGI-SS will be used to provide a clinical measure of the severity of schizophrenia. It is a single-item Likert scale with a 7-point range (0 indicates none to 7 indicates extreme symptoms).

    Measured: Up to Week 46

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2018
  2. Study start18 Oct 2018
  3. Primary completion2 Dec 2019
  4. Study completion2 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03713658
Sponsor's protocol ID
CR108551
Other IDs
R092670PSY4001
Status last verified
Apr 2025
First submitted
18 Oct 2018
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • Alphs L, Turkoz I, Smith-Swintosky V, Keenan A, Abraham E, Schotte A, Hooker E, Damascene Iyamuremye J, Kayiteshonga Y, Bizoza R, Mancevski B. Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system. BMJ Open. 2023 Apr 18;13(4):e064675. doi: 10.1136/bmjopen-2022-064675.

    PubMed 37072361

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Risperidone 3 mg, Paliperidone Palmitate 50 mg eq. and Paliperidone Palmitate 75 mg eq. in people with Schizophrenia, run by Janssen Research & Development, LLC at 3 sites in Rwanda.

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 5 inclusion and 5 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 3 sites in Rwanda. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Percentage of Participants With Successful Completion of Study Procedures (time frame: Up to Week 46). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03713658, which also lists 1 linked publication.

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.

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