Examination of the effect of silybum marianum on thyroid and antioxidant capacity in patients with bipolar disorders under the treatment of lithium

Determination of the silymarin's effect on thyroid parameters in patients with bipolar disorder treated with lithium.

Phase III clinical trial, with control group, with parallel groups, double blind, randomized, two groups consisting of 20 eligible individuals.

This study will be performed on patients admitted to hospitalize and outpatient of Farshchian Sina Hospital of Hamadan University of Medical Sciences and the relevant psychiatrist's office. Bipolar disorder is diagnosed in patients by a psychiatrist based on DSM-5. Patients were randomly divided into either drug or placebo groups. In the drug group, in addition to the standard treatments for depression in bipolar depression, silymarin is used at a dose of 140 mg daily for 16 weeks. In the placebo group, along with standard treatments, placebo is similar in appearance to the drug for 16 weeks.

Participants are men and women with an average age of 18 to 70 years. Inclusion criteria are: Patients with depression diagnosis of bipolar disorder by a psychiatrist based on DSM-5, patients receiving lithium. Exclusion criteria are asymptomatic mixed phase depression with manic or hypomanic syndrome, pregnant patients, lactating patients.

In general, two intervention and control groups will participate in this study. Subjects in the intervention group use silybum marianum. In the control group, a placebo silybum marianum pill form and color is used.

Thyroid indices T3, T4, TSH, Serum antioxidant capacity

For this purpose we will use quadratic random blocks method. For this purpose, we provide four sheets of paper for each drug and placebo group separately. We write on two sheets of letter A (intervention group) and on the other two sheets of letter C (comparison group). Mix the sheets together and place in a drawer. By referring to each eligible patient, one sheet was randomly drawn and the A or C sheet was drawn according to one of the two groups (silybum recipient) and control group Will be allocated. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been drawn. Once the four sheets have been randomly pulled out, all the sheets are returned to the drawer and the procedure will be repeated for the next four patients until the desired sample size is reached.

Patients were randomly divided into either drug or placebo groups. Both groups receive standard treatment with lithium and anti-psychotic drugs. In the drug group, in addition to the standard treatments for depression in bipolar depression, silybum is used at a dose of 140 mg daily for 10 weeks. In the placebo group, along with standard treatments, placebo is similar in appearance to the drug for 10 weeks. In this study, the researcher and treating physician who will examine patients will not be aware of the type of medication used for patients. Therefore, this study will be a double blind study.