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IRCT20191218045795N6 IRCT 2023-01-16 Sanandaj University of Medical Sciences The effect of L-carnitin as an adjunctive therapy in treatment of negative and positive symptom in schizophrenia The effect of L-carnitin as an adjunctive therapy in treatment of negative and positive symptom in schizophrenia 2023-01-21 anticipated 60 Complete https://irct.ir/trial/67250 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random blocks of 4 Patients are placed in two groups A and B by the assistant and using random block method. For this randomization, the cans that have been prepared in advance and the drugs in them are done by the pharmacist and based on the patients in the order provided by the statistical consultant. The patient and the outcome examiner are unaware of which of these two groups will receive the drug or the placebo. How to randomly assign: People are assigned to intervention and control groups using the method of forming random blocks of 4 as follows. AABB, ABAB, BBAA, BABA A: Intervention Group B: Control Group Up to 48 people will be randomized using the formation of random blocks of 4 and random selection from the sequence of these blocks. For the remaining two people, each of them will be assigned to one of the intervention and control groups using the lottery method, Blinding description: This study is done in a double blind way. The patients receiving the drug and the doctors who evaluate the outcomes are not aware of the random assignment of the subjects to the groups and the type of drug/placebo received. 3 Schizophrenia. Intervention 1: Intervention group: The drug used is l-carnitine 1000 mg, which is given to the intervention group daily for eight weeks, which is completely similar to the placebo drug in terms of weight and appearance. Intervention 2: Control group: The control group was given 1000 mg of placebo, which is mainly made of starch, flour, and coloring matter, and is completely similar to the main drug, L-carnitine, daily for eight weeks. Yes - There is a plan to make this available What will be shared: All personal data of participants can be shared after de-identification. When: The access period will start 6 months after the results are published. To whom: These data will be available to researchers working in academic and scientific institutions. Conditions: It will be determined after the completion of the study. Where to obtain: To receive the data, the request is sent via email (n.shamsalizadeh@muk.ac.ir) to the address of the main executive. How to obtain: The applicant must clearly specify the purpose of receiving the information. The duration of sending the documents will be two months. Comments:
public Narges Shamsalizadeh
Pasdaran Boulevard
sanandaj Iran (Islamic Republic of) 6617978743 +98 87 3366 4957 n.shamsalizadeh@muk.ac.ir Sanandaj University of Medical Sciences scientific Narges Shamsalizadeh
Pasdaran Blvd
sanandaj Iran (Islamic Republic of) 6617978743 +98 87 3366 4957 n.shamsalizadeh@muk.ac.ir Sanandaj University of Medical Sciences Iran (Islamic Republic of) Not having severe major depression based on Beck Depression Test (BECK Total score<29 have received psychiatric drugs with a fixed dose during the last 3 months. be treated with one of the second generation antipsychotic drugs 18 years 59 years Both Presence of another diagnosis based on DSM-5 Intellectual disability Received ECT in the past 2 months History of substance and drug use except nicotine and caffeine History of seizures F20 Schizophrenia Treatment - Drugs Placebo Intervention group: The drug used is l-carnitine 1000 mg, which is given to the intervention group daily for eight weeks, which is completely similar to the placebo drug in terms of weight and appearance. Control group: The control group was given 1000 mg of placebo, which is mainly made of starch, flour, and coloring matter, and is completely similar to the main drug, L-carnitine, daily for eight weeks. The score of positive and negative symptoms in the PANSS test. Timepoint: The beginning of the study, the end of the fourth week, the end of the eighth week. Method of measurement: Clinical interview based on PANSS. Metabolic syndrome. Timepoint: The beginning and end of the study. Method of measurement: Measurement of height and weight, blood pressure and waist circumference through clinical examination and measurement of triglycerides and cholesterol through paraclinics. Sanandaj University of Medical Sciences Approved 2022-09-21 Ethics Committee of Kurdistan University of Medical Sciences Pasdaran Street Sanandaj Kurdistan Iran (Islamic Republic of)