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IRCT20191218045795N8 IRCT 2023-02-28 Sanandaj University of Medical Sciences The effect of L-carnitine as an adjunct on cognitive abilities of patients with schizophrenia The effect of L-carnitine as an adjunct on cognitive abilities of patients with schizophrenia 2023-01-21 anticipated 60 Complete https://irct.ir/trial/67296 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is performed as a four block randomization. In this way, the sequence of four blocks, AABB, are numbered as six sequences of four, for example, ABBA, from one to six. A table of random numbers is extracted from the Excel program, and according to those fifteen numbers, it is determined that thirty of them are A and thirty to B. The order of referral is involuntarily and randomly placed in group A or group B. Obviously, patients do not have the right to choose group A or group B, 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) Schizophrenia according to DSM-5 Absence of any other disease that negatively affects the patient's cognitive processes (dementia, hypothyroidism, intellectual disability, ID... based on clinical interview) receiving a fixed dose of drugs such as anticholinergics (bipyridine...) and benzodiazepines during the last 1 month Receiving regular standard treatment and having a stable and controlled clinical condition during the last 1 month 18 years 50 years Both Coexistence of another psychiatric disorder according to DSM-5 Received ECT in the past 2 months Coexistence of substance abuse disorder and methadone according to DSM-5 Taking any medication that is prescribed due to cognitive problems or significantly affects the patient's cognitive processes F20 Schizophrenia Treatment - Drugs Treatment - Drugs 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. Increasing the cognitive abilities of patients with schizophrenia following the administration of L-carnitine. Timepoint: The beginning, middle and end of the study. Method of measurement: Wechsler Memory Scale Questionnaire (WMS) and Brief Mental State Examination (MMSE). Changes in CRP serum levels. Timepoint: The beginning and end of the study. Method of measurement: Serum sample collection and quantitative measurement of CRP. Sanandaj University of Medical Sciences Approved 2022-09-21 Ethics Committee of Kurdistan University of Medical Sciences Pasdaran Highway, Kurdistan University of Medical Sciences Sanandaj Kurdistan Iran (Islamic Republic of)