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IRCT20160530028173N5 IRCT 2023-12-12 Tabriz University of Medical Sciences Efficacy and side effects of risperidone, quetiapine and olanzapine in the treatment of Shisheh psychosis Comparison of the effects and side effects of the three drugs risperidone, quetiapine and olanzapine in the treatment of psychosis symptoms due to Shisheh 2023-11-22 anticipated 45 Complete https://irct.ir/trial/61989 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: analyst of the data were not aware of which group (risperidone, quetiapine and olanzapine) the sample was. Of course each sample has an special code. 3 psychosis symptoms due to Shisheh. Intervention 1: Patients will receive risperidone from Sobhan company daily in the therapeutic range of 2 to 8 mg. The patient will be evaluated by demographic questionnaire, urine test, PANSS positive and negative symptom tools once before starting the treatment and again after one month (according to DSM 5). Patients will be evaluated for drug side effects in the second and fourth weeks using the AIMS scale. In case of drug side effects, the patient will be excluded from the study and will continue the drug treatment process separately. In this regard, the patient's medication will be tapered and discontinued and will be changed to other medications. The substitute person will be entered in place of the exited sample, according to the entry and exit criteria. Intervention 2: Patients will receive Quetiapine drug of Tadbir Kalai Jam company in the therapeutic range of 25 to 100 mg daily. The patient will be evaluated by demographic questionnaire, urine test, PANSS positive and negative symptom tools once before starting the treatment and again after one month (according to DSM 5). Patients will be evaluated for drug side effects in the second and fourth weeks using the AIMS scale. In case of drug side effects, the patient will be excluded from the study and will continue the drug treatment process separately. In this regard, the patient's medication will be tapered and discontinued and will be changed to other medications. The substitute person will be entered in place of the exited sample, according to the entry and exit criteria. Intervention 3: Patients will receive Soban's Elanzapine drug in the therapeutic range of 5 to 10 mg daily. The patient will be evaluated by demographic questionnaire, urine test, PANSS positive and negative symptom tools once before starting the treatment and again after one month (according to DSM 5). Patients will be evaluated for drug side effects in the second and fourth weeks using the AIMS scale. In case of drug side effects, the patient will be excluded from the study and will continue the drug treatment process separately. In this regard, the patient's medication will be tapered and discontinued and will be changed to other medications. The substitute person will be entered in place of the exited sample, according to the entry and exit criteria. Yes - There is a plan to make this available What will be shared: Individual data including primary outcomes (drug effects and side effects) of participants can be shared after de-identification. When: The information will be available after analyzing the data and compiling the articles from 2024/09/21. To whom: The data will be accessible to health community researchers. Conditions: The data will be available for research purposes. Where to obtain: The data will be available through the study guide Dr. Arash Mohagheghi. How to obtain: The data will be available by sending a message to Dr. Arash Mohagheghi at the email address mohaggheghi@yahoo.com within one month after sending the email. Comments:
public Arash Mohagheghi
Razi Hospital, Elgoli Road
Tabriz Iran (Islamic Republic of) 5167846184 +98 41 3380 4486 mohaggheghi.a@gmail.com Tabriz University of Medical Sciences scientific Roya Mohammadi
Razi Hospital, elgoli road
Tabriz Iran (Islamic Republic of) 5167846184 009833804486 m.royaa1988@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Having criteria for glass-induced psychosis disorder based on DSM-5 (through clinical interview by psychiatrist). Treated with one of the antipsychotics risperidone, quetiapine and olanzapine No other psychiatric disorders Willingness of an individual or family (conscious consent) to participate in the study Minimum age 18 If you have a history of drug treatment for the above disorder, at least three weeks have passed since you stopped taking the drug 18 years no limit Both History of mental disorders History of epilepsy History of brain trauma Taking drugs other than target group treatment drugs Unwillingness of the patient or the family to continue cooperating in the study for any reason Incomplete questionnaires If a sample has other psychiatric disorders, including personality disorders, it will be excluded from the plan and will continue its routine treatment. Incidence of drug complications based on the AIMS scale f15 Other stimulant related disorders Treatment - Drugs Treatment - Drugs Treatment - Drugs Patients will receive risperidone from Sobhan company daily in the therapeutic range of 2 to 8 mg. The patient will be evaluated by demographic questionnaire, urine test, PANSS positive and negative symptom tools once before starting the treatment and again after one month (according to DSM 5). Patients will be evaluated for drug side effects in the second and fourth weeks using the AIMS scale. In case of drug side effects, the patient will be excluded from the study and will continue the drug treatment process separately. In this regard, the patient's medication will be tapered and discontinued and will be changed to other medications. The substitute person will be entered in place of the exited sample, according to the entry and exit criteria. Patients will receive Quetiapine drug of Tadbir Kalai Jam company in the therapeutic range of 25 to 100 mg daily. The patient will be evaluated by demographic questionnaire, urine test, PANSS positive and negative symptom tools once before starting the treatment and again after one month (according to DSM 5). Patients will be evaluated for drug side effects in the second and fourth weeks using the AIMS scale. In case of drug side effects, the patient will be excluded from the study and will continue the drug treatment process separately. In this regard, the patient's medication will be tapered and discontinued and will be changed to other medications. The substitute person will be entered in place of the exited sample, according to the entry and exit criteria. Patients will receive Soban's Elanzapine drug in the therapeutic range of 5 to 10 mg daily. The patient will be evaluated by demographic questionnaire, urine test, PANSS positive and negative symptom tools once before starting the treatment and again after one month (according to DSM 5). Patients will be evaluated for drug side effects in the second and fourth weeks using the AIMS scale. In case of drug side effects, the patient will be excluded from the study and will continue the drug treatment process separately. In this regard, the patient's medication will be tapered and discontinued and will be changed to other medications. The substitute person will be entered in place of the exited sample, according to the entry and exit criteria. Positive Symptoms Severity. Timepoint: Before the intervention, one month after the intervention. Method of measurement: PANSS positive and negative symptom scale. Negative Symptoms Severity. Timepoint: Before the intervention, one month after the intervention. Method of measurement: PANSS positive and negative symptom scale. Tabriz University of Medical Sciences Approved 2023-10-21 Ethics committee of Tabriz University of Medical Sciences International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street Tabriz East Azarbaijan Iran (Islamic Republic of)