The study of the effects of adding folic acid to the therapeutic diet (citalopram) in patients with depression.

Summary: Objectives: Optimal level of folates is essential for normal functioning of the brain and body. Recently, studies have focused on the effect of folates on cognitive disorders. More recent studies have demonstrated that plasma levels of folates in people with mood disorders such as depression is less than desirable. This research is designed to determine the effects of folic acid on patients with depression. Main outcome: The effect of adding folic acid to the therapeutic diet (citalopram) in patients with depression. Design: This study is a clinical trial. The study population is all patients with depression referred to Kermanshah Farabi Hospital. The sample size consists of 60 patients who would be chosen by available method and divided in two equal groups. Citalopram in a dose of 60 mg/d will be prescribed in both groups. The study group will receive folic acid at a dose of 5 mg once daily. In controls placebo will be recommended once daily. Setting and conduct: Maximum replication between the study and control groups would be done. A psychiatrist determines the treatment program. Faculty of Pharmacy of Kermanshah University of Medical Sciences is responsible for supplying placebo. Beck Standard Inventory is used to measure the severity of symptoms. A bachelor in clinical psychology, who is not aware of treatment, will use the questionnaire. This questionnaire includes of 21 questions. The total score ranges are from 0 to 63 which specifies four degrees of depression as follows: 0 to 10 normal; 11 to 16, slightly depressed; 17 to 20 require a consultation with the doctor; 21 to 30 moderately depressed; 31 to 40 severe depression, and higher than 41 very sever depression. The valuation and improvements of the patients will be measured at the first visit; 2 weeks later; first month; and second and third months then after. Profiles of drug treatment, including medication times, changes and reasons for changes in dosage or discontinuation of therapy will be recorded on a special form. At each step and at the end of the survey, evaluation of symptoms, side effects of drug therapy, and the response to treatment will be discussed. Inclusion criteria: age>18years; having diagnosis of depression (DSM.IV.TR). Exclusion criteria: IQ<70; schizophrenia; major medical or neurological disorders; pregnancy; contraindication for using of folates; and gastric or renal disorders. The sampling period would last about two years. The expected outcome is an improvement in depression symptoms in response to folic acid therapy.

Kermashah University of Medical Sciences