The effect of L-carnitin as an adjunctive therapy in treatment of negative and positive symptom in schizophrenia

1- To improve positive and negative symptoms in patients with schizophrenia 2- To reduce the profile of fats, reduce cardiovascular diseases, improve the metabolism of fats in patients with schizophrenia, 3- To reduce the cost of treatment of diseases caused by the effects of metabolic disorders and the effects of drug treatment.

Clinical trial with control group, parallel group, double-blind, randomized, phase 3 on 60 patients, four-way randomization block method was used for randomization.

In this study, after the preparation of L-carnitine and placebo medicine, which no one except the drug maker (plan manager, nurse, patient caregivers) knows about, is given to patients admitted to Quds Hospital in Sanandaj or care centers in Sanandaj city.

1- Not having severe major depression based on Beck depression test (BECK Total score<29) 2- Be treated with one of the second generation antipsychotic drugs. 3- If there is another diagnosis based on DSM-5, it will be excluded from the study.

The intervention group was given one gram of L-carnitine daily for eight weeks. The control group was given one gram of placebo (starch) daily for eight weeks.

Reduction of positive and negative symptoms, as well as reduction of side effects caused by antipsychotic drugs and schizophrenia itself, which is seen as metabolic syndrome.

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.

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.

All personal data of participants can be shared after de-identification.

The access period will start 6 months after the results are published.

These data will be available to researchers working in academic and scientific institutions.

It will be determined after the completion of the study.

To receive the data, the request is sent via email (n.shamsalizadeh@muk.ac.ir) to the address of the main executive.

The applicant must clearly specify the purpose of receiving the information. The duration of sending the documents will be two months.