Saffron stigma in women with no major postpartum depressio

Phase 2

• Conditions: postpartum depression.; Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified

• Registration Number: IRCT2015121714477N2
• Lead Sponsor: Mashhad university of medical sciences? Vice chancellor for research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

Subjects for this study will meet the following criteria: Age 18 to 40 years; A history of at least two weeks with postpartum-related mood disturbances of mild or moderates, and self-report of the onset of depression within three months of a normal vaginal delivery or uncomplicated Caesarean section; A current episode of no major depression (meeting 3-4 criterion symptoms determined by clinical interview). Additionally, to ensure that subjects meet a minimum threshold for severity of depression, subjects will have scores greater than or equal to 11 on the Beck Depression Inventory (BDI-II). During at least two clinic visits during the screening phase;Not greater than six months post delivery; In good medical health, and not taking any medication or dietary and herbal supplements on a regular basis (with the exception of multivitamins or calcium supplements). Subjects will be excluded if they meet any of the following criteria: Severe major depression with postpartum psychosis, suicidal ideation or anyone requiring immediate treatment after clinical assessment; Current treatment with antidepressant medications or prior hormonal therapy for the treatment of postpartum-related mood or physical symptoms within the last six months; History of psychiatric illness during the two years before the reported onset of the current episode of depression or a history of either mania or postpartum psychosis at any time in the past; History of anticoagulant therapy; Renal disease; Patients with a known hypersensitivity of saffron.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean decrease in BDI-II score. Timepoint: weeks 0,4,8. Method of measurement: self-rating BDI-II scales.