- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06657430
A Study on the Preference of Risperidone Dosage Forms
October 23, 2024 updated by: Shanghai Mental Health Center
This study aimed to understand patients' needs and preferences for antipsychotic dosage forms.
Study Overview
Status
Recruiting
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 Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lan Luo, Doctor of Medicine
- Phone Number: +8618516544150
- Email: lan-luo@foxmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200030
- Recruiting
- Shanghai Mental Health Center
-
Contact:
- Lan Luo, Doctor of Medicine
- Phone Number: +8618516544150
- Email: lan-luo@foxmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with schizophrenia, bipolar disorder, autism spectrum disorder, mental retardation or their primary caregivers who voluntarily participate in the study.
Description
Inclusion Criteria:
- Patients with schizophrenia, bipolar disorder, autism spectrum disorder, mental retardation or their primary caregivers who voluntarily participate in the study.
Exclusion Criteria:
- Have difficulty reading and understanding Chinese or refuse to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
"through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Factors related to patients' preference for risperidone patch-form medicines
Time Frame: through study completion, an average of 6 months
|
Patients' evaluation of the importance of each advantage of risperidone patch in a self-made questionnaire (5-point Likert scale score)
|
through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 2024
Primary Completion (Estimated)
February 28, 2025
Study Completion (Estimated)
February 28, 2025
Study Registration Dates
First Submitted
October 21, 2024
First Submitted That Met QC Criteria
October 23, 2024
First Posted (Actual)
October 24, 2024
Study Record Updates
Last Update Posted (Actual)
October 24, 2024
Last Update Submitted That Met QC Criteria
October 23, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bipolar and Related Disorders
- Neurologic Manifestations
- Nervous System Diseases
- Schizophrenia Spectrum and Other Psychotic Disorders
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Attention Deficit and Disruptive Behavior Disorders
- Autism Spectrum Disorder
- Schizophrenia
- Bipolar Disorder
- Mood Disorders
- Intellectual Disability
- Conduct Disorder
Other Study ID Numbers
- 2024-85
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Fundació Institut de Recerca de l'Hospital de la...Recruiting
-
First Affiliated Hospital of Fujian Medical UniversityNot yet recruiting
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Newron Pharmaceuticals SPARecruitingTreatment-resistant SchizophreniaUnited States, India
-
Bradley LegaRecruiting
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
All India Institute of Medical Sciences, BhubaneswarCompletedTreatment Resistant SchizophreniaIndia
-
Second Xiangya Hospital of Central South UniversityNot yet recruiting
-
Kaohsiung Medical University Chung-Ho Memorial...Not yet recruitingSchizophrenia Disorder
-
Shanghai Zhongze Therapeutics Co., Ltd.Yale UniversityNot yet recruiting