Comparison of Serum Prolactin Concentrations after Administration of Long-Acting Injectable Risperidone and Oral Risperidone Tablets in Patients with Psychotic Disorders

Comparison of the effect of long-acting injectable risperidone and oral risperidone tablets on serum prolactin concentration

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.

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.

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.

The first group will be treated with oral risperidone and the second group will be treated with long-acting injectable risperidone.

Serum prolactin level

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.

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 Informed consent form: The raw form will be published, but the form related to each patient can not be published due to the fact that it contains the patient's name and some personal information, but will remain with the researcher.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

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.

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)

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.

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.

‏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.