Summary
Saffron (Crocus sativus) has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Major Depressive Disorder. No registered clinical trial in this database tests Saffron (Crocus sativus) specifically in Major Depressive Disorder. The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study. The literature layer holds 6 publications for this pair: 1 meta-analysis, 1 systematic review and 4 clinical trial publications. Publication years run from 2012 to 2017. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Major Depressive Disorder ranks 580 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Relapse in 19-45% within 1 year of antidepressant discontinuation after remission; relapse risk ratio (off-medication vs on) falls from 3.69x at 2 months to 1.34x at 5 years.
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 20.0 (trials 0.0, literature 15.0, tier 5, approved bonus 0.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 6 (4 clinical trial publications, 1 meta-analysis, 1 systematic review) |
| Agent type | Supplement (Herbal) |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Integrative interventions for improving outcomes in depression: a narrative review · Halma M, Plothe C, Marik PE · 2024 |
| Data sources | OSMF Chronic Disease Review |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
No registered trial links Saffron (Crocus sativus) to Major Depressive Disorder in the current OSMF trial extract.
Published literature
- Clinical trial publication Crocus sativus L. versus Citalopram in the Treatment of Major Depressive Disorder with Anxious Distress: A Double-Blind, Controlled Clinical TrialGhajar A, Neishabouri SM, Velayati N et al. · Pharmacopsychiatry · 2017 · PMID 27701683
- Clinical trial publication Crocin, the main active saffron constituent, as an adjunctive treatment in major depressive disorder: a randomized, double-blind, placebo-controlled, pilot clinical trialTalaei A, Hassanpour Moghadam M, Sajadi Tabassi SA et al. · Journal of affective disorders · 2015 · PMID 25484177
- Systematic review A systematic review of randomized controlled trials examining the effectiveness of saffron (Crocus sativus L.) on psychological and behavioral outcomesHausenblas HA, Heekin K, Mutchie HL et al. · Journal of integrative medicine · 2015 · PMID 26165367
- Clinical trial publication Saffron for treatment of fluoxetine-induced sexual dysfunction in women: randomized double-blind placebo-controlled studyKashani L, Raisi F, Saroukhani S et al. · Human psychopharmacology · 2013 · PMID 23280545
- Meta-analysis Saffron (Crocus sativus L.) and major depressive disorder: a meta-analysis of randomized clinical trialsHausenblas HA, Saha D, Dubyak PJ et al. · Journal of integrative medicine · 2013 · PMID 24299602
- Clinical trial publication Effect of saffron on fluoxetine-induced sexual impairment in men: randomized double-blind placebo-controlled trialModabbernia A, Sohrabi H, Nasehi AA et al. · Psychopharmacology · 2012 · PMID 22552758
Mechanism and notes
Recorded mechanism or class: Integrative interventions for improving outcomes in depression: a narrative review · Halma M, Plothe C, Marik PE · 2024.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Saffron (Crocus sativus) approved for Major Depressive Disorder?
Saffron (Crocus sativus) has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Major Depressive Disorder. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Saffron (Crocus sativus) in clinical trials for Major Depressive Disorder?
No registered clinical trial in this database tests Saffron (Crocus sativus) specifically in Major Depressive Disorder. The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study.
What does the evidence show for Saffron (Crocus sativus) in Major Depressive Disorder?
Synthesis-level literature links Saffron (Crocus sativus) to Major Depressive Disorder, but no registered trial in this database tests the pair, so the evidence is observational, pooled from other indications, or pre-dates registry practice. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.