The effect of adding saffron to fluoxetine in the treatment of mild to moderate depression in type 2 diabetes mellitus patients: A Randomized Double-Blinded Study

The effect of adding saffron to fluoxetine in the treatment of mild to moderate depression in type 2 diabetes mellitus patients

This is a clinical trial study with parallel groups, double-blinded randomized, phase 3. Allocation of patients to the study groups will be done by random numbers generation and using computer by excel software

This study will be performed on 60 patients with type 2 diabetes mellitus with a diagnosis of mild to moderate depression in Imam Khomeini hospital, Ahvaz. The patients will be randomly assigned to one of two treatment groups. The patients and experimenters will not know about type of treatment and patient grouping and thus until the end of trial the study will be remained double-blinded.

Inclusion criteria: age 18-60 years, diabetes mellitus type 2, mild to moderate depression, consent to participate in the study; Exclusion criteria: Consumption of psychiatric drugs before the study, substance abuse, insulin consumption, uncontrolled diabetes, history of severe stress, pregnancy, lactation, other psychiatric illnesses including anxiety disorders, Previous history of depression, Mental disability.

Intervention group: Fluoxetine 10 mg, once a day (Abidi Pharmaceutical Company, Iran) will be prescribed for 4 weeks and then the patients will be received Deprofade saffron capsule 20 mg per day (Tolou Gostar Bokhara Company, Iran) along with fluoxetine 10 mg for 4 weeks. Control group: Fluoxetine 10 mg will be prescribed for 4 weeks and then patients will be received a similar capsule containing placebo (prepared in the Faculty of Pharmacy of Ahvaz Jundishapur University) along with fluoxetine for 4 weeks.

The severity of depression and incidence of treatment-related complication

Patients will be assigned into two groups by simple randomization method. Allocation of patients to the study groups will be done by random numbers generation and using computer by excel software. Random numbers will be generated in Excel with RAND function [(=RAND()*(60)] and with this function 60 random numbers will be created in the range of 1 to 60 in a column. Each patient will be assigned a two-digit code from 01 to 60. From the beginning of the first row, move down the column of random numbers and check the first two digits of the random numbers. The first 30 people seen in our code range will be placed in the first group (intervention) and the second 30 people will place in the second group (control). A person from hospital staff, who will not responsible for patient selection, enrollment, or treatment allocation, performs the randomization. The patients will be included in one of the two treatment groups before starting treatment. The implementation of the random allocation sequence occurs without knowledge of which patient will receive which treatment.

In this study, physicians, nurses, data collectors, those assessing the consequences, and the Safety and Data Monitoring Committee will be kept blind. In order to eliminate the bias caused by the knowledge of them, the results are based on the type of treatment received and its possible impact on the research result of the study in a double-blind manner. The appearance of the placebo will be similar to that of saffron capsule. Also patients and statistical analyzer will not know about patient grouping.