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IRCT20221003056082N1 IRCT 2023-01-11 University of social welfare and rehabilitation sciences Effect of Oral and Injectable Risperidone on Prolactin in Psychotic Patients Comparison of Serum Prolactin Concentrations after Administration of Long-Acting Injectable Risperidone and Oral Risperidone Tablets in Patients with Psychotic Disorders 2023-02-04 anticipated 60 Complete https://irct.ir/trial/67806 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. 3 The effect of oral and injectable risperidone on serum prolactin level. Intervention 1: The first intervention group: Oral risperidone 2 mg two or three times a day for two weeks. Intervention 2: The second intervention group: Long-acting injectable risperidone 25 mg on the first and seventh days. Yes - There is a plan to make this available What will be shared: 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 Informed consent form: The raw form will be published, but the form related to each patient can not be published due to the fact that it contains the patient's name and some personal information, but will remain with the researcher.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 When: 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. To whom: 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) Conditions: 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. Where to obtain: 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. How to obtain: ‏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. Comments:
public Dr.Ali Nazriastaneh
Kudakyar Deadend, Daneshju Blvd, Evin
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7173 2000 a.nazeri@uswr.ac.ir University of social welfare and rehabilitation sciences scientific Dr. Ali Nazeriastaneh
Kudakyar Deadend, Daneshju Blvd, Evin
Tehran Iran (Islamic Republic of) 1985713834 +98 21 7173 2000 a.nazeri@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) 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 18 years 60 years Both Patients with high prolactin levels Patients with hypothyroidism Patients with impaired liver or kidney tests Pregnant women Treatment - Drugs Treatment - Drugs The first intervention group: Oral risperidone 2 mg two or three times a day for two weeks The second intervention group: Long-acting injectable risperidone 25 mg on the first and seventh days Serum prolactin level. Timepoint: 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. Method of measurement: Prolactin laboratory kit. Fasting blood sugar. Timepoint: Before the intervention and on the fourteenth day after the intervention. Method of measurement: Blood sugar laboratory kit. Blood triglycerides. Timepoint: Before the intervention and on the fourteenth day after the intervention. Method of measurement: Triglyceride laboratory kit. Blood cholesterol. Timepoint: Before the intervention and on the fourteenth day after the intervention. Method of measurement: Cholesterol laboratory kit. University of social welfare and rehabilitation sciences Approved 2022-09-21 Ethics committee of University of Rehabilitation Sciences and Social Health Kudakyar Deadend, Daneshju Blvd, Evin Tehran Tehran Iran (Islamic Republic of)