Main outcome:
Appointment of the effect of adding folic acid to the sodium valproate in response to treatment of patients with mania.
Design:
This study is a clinical trial. The study population includes 60 patients out of all patients with mania whom referred to Farabi Hospital. They will be divided in two equal groups. Patients in the study group will receive sodium valproate, one atypical anti psychotic drug, and folic acid (at a dose of 5 mg once daily). Yet the patients in the control group will be treated with an atypical antipsychotic, sodium valproate, and a placebo instead of folic acid. The sampling will be done by available method.
Setting and conduct:
Maximum replication between the study and control groups to apply. Therapeutic regimen program will be determined by a psychiatrist. Education Directory of Faculty of Pharmacy of Kermanshah University of Medical Sciences is responsible for supplying placebo. Evaluation and improvement of symptoms is determined by a bachelor in Clinical Psychology, who is not aware of the treatment program. The patients should be visited in the beginning of the study, and at intervals of two weeks in the first month and then monthly for two months later, to be evaluated by the Young Mania Rating Scale (YMRS). This scale includes 11 items, and is used to determine the presence and severity of the symptoms of manic disorder. Profile of drug treatment, including medication times per day, changes and reasons for changing the dosage or discontinuation of therapy and time of discontinuation will be recorded on a special form at each step and at the end of the study. Evaluation of symptoms, side effects of drugs, and the response to treatment will be recorded.
This is an accidentally double blind study by using placebo controls which is conducted in Farabi Hospital. Inclusion criteria are: being older than 18 years; having diagnosis of BD type 1, 2 (DSM-IV-TR). Exclusion criteria include: IQ lower than 70; and contraindications of folate consumption. Sampling period would last two years, and the expected result is to increase response to adding folate to sodium valproate in patients with mania.