Protocol summary
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Study aim
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Comparison of the effect of long-acting injectable risperidone and oral risperidone tablets on serum prolactin concentration
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Design
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Phase 3 randomized parallel group clinical trial on 60 patients who will be divided into two groups of 30 people by simple randomization and using a table of random numbers.
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Settings and conduct
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60 patients with psychotic disorders who are hospitalized in Rey Town Razi Psychiatric Hospital will be randomly divided into two groups of 30 and will be treated with oral risperidone (with a therapeutic dose of 4-6 mg daily) or long-acting injectable risperidone (Two injections of 25 mg suspension on the first and seventh days). Baseline serum prolactin concentration will be measured before starting the treatment and after starting the treatment on the first day, the seventh day and the fourteenth day. Also, due to the metabolic side effects of antipsychotic drugs, the blood sugar level and fat profile of the patients will be measured before the start of the treatment and after that on the fourteenth day.
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Participants/Inclusion and exclusion criteria
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Patients aged 18 to 60 with psychotic disorders who are candidates for receiving antipsychotic drugs and have not used these drugs in the last year can enter the study. Pregnant women and those with thyroid, kidney, liver or high prolactin function tests will not be included in the study.
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Intervention groups
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The first group will be treated with oral risperidone and the second group will be treated with long-acting injectable risperidone.
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Main outcome variables
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Serum prolactin level
General information
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Reason for update
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Due to the clinical conditions of the acute psychiatric ward and ethical and practical limitations in randomizing patients with acute psychosis, the study design was changed from a clinical trial to a prospective observational cohort study before the data analysis stage.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221003056082N1
Registration date:
2023-01-11, 1401/10/21
Registration timing:
prospective
Last update:
2026-09-05, 1405/06/14
Update count:
1
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Registration date
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2023-01-11, 1401/10/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-02-04, 1401/11/15
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Expected recruitment end date
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2023-08-06, 1402/05/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of Serum Prolactin Concentrations after Administration of Long-Acting Injectable Risperidone and Oral Risperidone Tablets in Patients with Psychotic Disorders
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Public title
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Effect of Oral and Injectable Risperidone on Prolactin in Psychotic Patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18 to 60 years
Having a psychotic disorder
No mood disorder
A candidate for antipsychotics
Not using antipsychotic drugs in the last year
Patient satisfaction and cooperation
Exclusion criteria:
Patients with high prolactin levels
Patients with hypothyroidism
Patients with impaired liver or kidney tests
Pregnant women
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Sampling is done by simple random sampling. First, among hospitalized patients, we select 60 patients who meet the entry criteria and prepare a list of names in alphabetical order and divide the patients into two desired groups using random number table software. Thus, for each person, if a random number between zero and 0.5 is determined, they enter the oral group, and if a number greater than half is determined, they enter the injectable group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-09-21, 1401/06/30
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Ethics committee reference number
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IR.USWR.REC.1401.089
Health conditions studied
1
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Description of health condition studied
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The effect of oral and injectable risperidone on serum prolactin level
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Serum prolactin level
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Timepoint
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Before starting the treatment and on the first day, the seventh day and the fourteenth day after starting the treatment with oral or injectable risperidone
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Method of measurement
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Prolactin laboratory kit
Secondary outcomes
1
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Description
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Fasting blood sugar
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Timepoint
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Before the intervention and on the fourteenth day after the intervention
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Method of measurement
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Blood sugar laboratory kit
2
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Description
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Blood triglycerides
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Timepoint
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Before the intervention and on the fourteenth day after the intervention
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Method of measurement
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Triglyceride laboratory kit
3
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Description
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Blood cholesterol
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Timepoint
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Before the intervention and on the fourteenth day after the intervention
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Method of measurement
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Cholesterol laboratory kit
Intervention groups
1
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Description
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The first intervention group: Oral risperidone 2 mg two or three times a day for two weeks
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Category
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Treatment - Drugs
2
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Description
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The second intervention group: Long-acting injectable risperidone 25 mg on the first and seventh days
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of social welfare and rehabilitation sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Participants data file: After unrecognizabling the individuals, the section on the main outcome and results of the study will be published and other information will be kept by the researcher and will be available to other researchers if needed.
Study protocol: How to do the study in detail will be published.
Informed consent form: The raw form will be published, but the form related to each patient can not be published due to the fact that it contains the patient's name and some personal information, but will remain with the researcher.
Clinical study report: The result of the study will be published in a transparent manner along with the result of statistical analysis
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When the data will become available and for how long
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6 months after the end of the study and the final analysis, the initial information will be published, the final results will be available at the same time as the results are published.
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To whom data/document is available
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Access to the research project is based on the university mechanism and the rules of the educational center and is available for academic and scientific institutions. If the article is published, the results will be available to the public (subject to the rules of the relevant journal)
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Under which criteria data/document could be used
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Access to non-personally identifiable data and other documents is under the supervision of the University Ethics Committee and at the discretion of that authority, will be accessible in a limited way for additional research.
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From where data/document is obtainable
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Applicants can go in person to the psychosis research center affiliated with the University of Rehabilitation Sciences and Social Health located in Razi Psychiatry Hospital at the address of shahid Rastegar Blvd, Varamin Road, Rey Town., or contact the director of the center, Dr. Ali Nazeriastaneh, and the expert of the center, Mr. Bakhtevar, through phone number 021-33401220-29. They can also email their request to psychosisrc@uswr.ac.ir. Additional information is available on the center's website at psychosis.uswr.ac.ir.
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What processes are involved for a request to access data/document
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Submitting an application to the Psychosis Research Center, reviewing the application by the university's ethics committee, if approved by the university as well as obtaining approval and consent from the lead researcher regarding the use of data in another study, documents will be available.
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Comments
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