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IRCT20190621043962N1 IRCT 2019-09-19 Mashhad University of Medical Sciences Evaluation of the effects of add-on treatment with Atorvastatin on cognitive deficits in schizophrenic patients Evaluation of the effects of add-on treatment with Atorvastatin on cognitive deficits in schizophrenic patients 2019-08-23 anticipated 64 Complete https://irct.ir/trial/40408 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The form of drug and placebo are similar and the patients and evaluators are blind in regards to their study group assignment. Drug and placebo will be prepared in closed packs and labeled with specific codes by the pharmacologist, Blinding description: The form of drug and placebo are similar and the patients and evaluators are blind in regards to their study group assignment. Drug and placebo will be prepared in closed packs and labeled with specific codes by the pharmacologist. N/A schizophrenia. Intervention 1: Intervention group: The intervention group will take Atorvastatin tablet (20 milligram) once daily via oral route for 6 weeks. This drug will be produced by the Pharmacology department of Mashhad University of Medical Sciences. Intervention 2: Control group: The control group will take placebo tablet once daily via oral route for 6 weeks. This drug will be produced by the Pharmacology department of Mashhad University of Medical Sciences. Yes - There is a plan to make this available What will be shared: The results of this clinical study will be published in an article When: The results will be accessible to public after study completion To whom: The results of this study will be open for public access in all national and international journals Conditions: Files will be accessible after they are approved by the ethics committee of Mashhad University of Medical Sciences Where to obtain: Vice-chancellor of Research and Technology, Mashhad University of Medical Sciences How to obtain: For access to files, you can refer to Vice-chancellor of Research and Technology of Mashhad University of Medical Sciences Comments:
public Zahra Soleimani
Horre Ameli Blvd , Mashhad
Mashhad Iran (Islamic Republic of) 9317744839 +98 51371127017 drsoleimani92@gmail.com Mashhad University of Medical Sciences scientific Zahra Soleimani
Horre Ameli Blvd , Mashhad
Mashhad Iran (Islamic Republic of) 9317744839 +98 371127017 drsoleimani92@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Diagnosis of schizophrenia based on DSM-5 patients between 18 and 64 years Informed consent by the patients and a member of his/her family Minimum eighth grade education No psychiatric comorbidity No medical comorbidity No substance use, except for cigarettes No history of hypersensitivity reaction or intolerable side effects with Atorvastatin No concomitant drugs that they interact with Atorvastatin (Anti-inflammatory drugs such as Aspirin and Ibuprofen, Thiazide diuretics, weight-loss drugs, anti-fungal drugs, Macrolids, Colchicin, Protease inhibitors) No pregnancy or breastfeeding (for women) No history of major head trauma No participation in other study in the time of this study No major cognitive deficits comorbidity 18 years 64 years Both Failure to the patient or his/her family to continue the study Occurrence of any serious side effects during the study F20 Schizophrenia Treatment - Drugs Treatment - Other Intervention group: The intervention group will take Atorvastatin tablet (20 milligram) once daily via oral route for 6 weeks. This drug will be produced by the Pharmacology department of Mashhad University of Medical Sciences Control group: The control group will take placebo tablet once daily via oral route for 6 weeks. This drug will be produced by the Pharmacology department of Mashhad University of Medical Sciences Cognitive state. Timepoint: At the outset of the study (before intervention), at 21 days 42 days after starting Atorvastatin. Method of measurement: PANSS test, Stroop test, Digit span test, Verbal fluency test, Wechsler test, Wisconsin Card Sorting test, and Trial making test. Positive and negative symptoms score. Timepoint: At the outset of the study (before intervention), and at 3 and 6 weeks after starting Atorvastatin. Method of measurement: Positive and Negative Symptoms Scale test. Mashhad University of Medical Sciences Approved 2019-06-17 Ethics committee of Mashhad University of Medical science Vice-chancellor of Research and Technology, Mashhad University of Medical Sciences, Daneshgah St, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)