IRCT20130418013058N11.

Study name	The effect of crocin and sertraline in mild to moderate postpartum depression in two treatment groups (sertraline and crocin); a randomized placebo controlled clinical trial
Methods	Double blind, 2‐arm RCT
Participants	Inclusion criteria: patients with PPD according to DSM‐V Scale; 14 score of BDI; age range 18‐45 years old; have a healthy, live and single baby; not receiving any psychiatric medication 5 weeks before the start of the study; written consent for participation Exclusion criteria: other psychiatric disorders such as behavioral disorder, bipolar disorder and schizophrenia, drug abuse; history of chronic and systematic diseases; restrictive living conditions that cause the patient to not complete the course of treatment and need another drug; sensitivity to saffron; having other symptoms of psychosis or suicidal tendencies or any other mental disorder; medical problems such as pre‐eclampsia and diabetes during pregnancy; symptoms of psychosis and thoughts of suicide or child abuse
Interventions	Women were randomised to: 15 mg/day of crocin capsule for 3 months. Crocin is a herbal product and an active constitute of saffron 50 mg /day of sertraline capsule for 3 months
Outcomes	Primary outcomes: depression (BDI) at 1, 2 and 3 months after randomisation Secondary outcomes: side effects of crocin
Starting date	3 Sepetmber 2018
Contact information	Seyed Ahmad Mohajeri Pharmaceutical Research Center, School Of Pharmacy, Mashhad University of Medical Sciences, Iran (Islamic Republic of) Email: mohajeria@mums.ac.ir
Notes

BDI: Beck Depression Inventory; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; HAMD‐17: Hamilton Depression Rating Scale, 17‐item version; Hz: Hertz; PPD: postpartum depression; RCT: randomised controlled trial; rTMS: repetitive Transcranial Magnetic Stimulation