SchizophreniaNCT06657430
A Study on the Preference of Risperidone Dosage Forms
An observational study of Schizophrenia and Bipolar Affective Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study aimed to understand patients' needs and preferences for antipsychotic dosage forms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Affective Disorder, Autism Spectrum Disorder
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2024to 28 Feb 2025
- 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: Patients with schizophrenia, bipolar disorder, autism spectrum disorder, mental retardation or their primary caregivers who voluntarily participate in the study.
Who may be able to join
- Patients with schizophrenia, bipolar disorder, autism spectrum disorder, mental retardation or their primary caregivers who voluntarily participate in the study.
Who cannot join
- Have difficulty reading and understanding Chinese or refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Lan Luo, Doctor of Medicine, +8618516544150, lan-luo@foxmail.com
About this study
This study aimed to understand patients' needs and preferences for antipsychotic dosage forms.
Read the detailed description
This study aims to understand patients' needs and preferences for antipsychotic dosage forms and to clarify the clinical value of patch-form antipsychotics.
- Conditions
- Schizophrenia, Bipolar Affective Disorder, Autism Spectrum Disorder, Conduct Disorder, Mental Retardation
- Keywords
- risperidone, patch, cross-sectional study, preference
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder, Conduct Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients and their caregivers | Patients (and their caregivers) with psychiatric disorders for which risperidone is indicated, including schizophrenia, bipolar disorder, autism spectrum disorder, conduct disorder, and mental retardation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients (and their caregivers) who prefer risperidone patch-form medicine
The proportion of patients (and their caregivers) who preferred risperidone patch among the respondents in this study
Measured: "through study completion, an average of 6 months
Secondary outcomes (1)
Factors related to patients' preference for risperidone patch-form medicines
Patients' evaluation of the importance of each advantage of risperidone patch in a self-made questionnaire (5-point Likert scale score)
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start19 Sep 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657430
- Sponsor's protocol ID
- 2024-85
- Status last verified
- Sep 2024
- First submitted
- 21 Oct 2024
- Last updated
- 24 Oct 2024
- 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 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Preference of Risperidone Dosage Forms
- ClinicalTrials.gov ID
- NCT06657430
- Acronym / sponsor ID
- 2024-85
- Conditions
- Schizophrenia, Bipolar Affective Disorder, Autism Spectrum Disorder, Conduct Disorder, Mental Retardation
- Keywords
- risperidone, patch, cross-sectional study, preference
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 24 Oct 2024 (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.
This study aimed to understand patients' needs and preferences for antipsychotic dosage forms.
Detailed description
This study aims to understand patients' needs and preferences for antipsychotic dosage forms and to clarify the clinical value of patch-form antipsychotics.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients and their caregivers | – | –Patients (and their caregivers) with psychiatric disorders for which risperidone is indicated, including schizophrenia, bipolar disorder, autism spectrum disorder, conduct disorder, and mental retardation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with schizophrenia, bipolar disorder, autism spectrum disorder, mental retardation or their primary caregivers who voluntarily participate in the study.
Key inclusion criteria (1 listed)
- Patients with schizophrenia, bipolar disorder, autism spectrum disorder, mental retardation or their primary caregivers who voluntarily participate in the study.
Key exclusion criteria (1 listed)
- Have difficulty reading and understanding Chinese or refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients (and their caregivers) who prefer risperidone patch-form medicine
Time frame: "through study completion, an average of 6 months
The proportion of patients (and their caregivers) who preferred risperidone patch among the respondents in this study
1 secondary outcome
Factors related to patients' preference for risperidone patch-form medicines
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar Affective Disorder, run by Shanghai Mental Health Center at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lan Luo, Doctor of Medicine (+8618516544150, lan-luo@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients (and their caregivers) who prefer risperidone patch-form medicine (time frame: "through study completion, an average of 6 months). 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 Oct 2024.