Efficacy of Saffron in the treatment of major depressive disorder, with anxious distress
Phase 2
- Conditions
- Major Depressive episode.Depressive episode
- Registration Number
- IRCT201501041556N71
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1-Presence of Major Depressive Disorder, with anxious distress based on DSM-5 criteria; 2- age between 18 to 65 years old; 3-score lower than 20 in Hamilton Rating Scale for depression.
Exclusion criteria: 1-Psychotic symptoms; 2-receiving another psychotropic medications; 3-receiving any antidepressants during past one month or ECT during past two months; 4-Presence of hypothyroidism; 5-nursing and pregnant women; 6-srious suicidality during the last year; 7-women who want to be pregnant during the future months; 8-women who are receiving OCP; 9-receiveng aspirin and anticoagulants and NSAIDs.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of anxiety. Timepoint: Baseline and weeks: 2, 4 and 6 after beginig of treatment. Method of measurement: By Hamiltion Anxiety Rating Scale.;Severity of depression. Timepoint: Baseline and weeks: 2, 4 and 6 after beginig of treatment. Method of measurement: By HamiltionDepression Rating Scale.
- Secondary Outcome Measures
Name Time Method