Management Strategy for Mild to Moderate Major Depression: Combination of Rhodiola and Saffron Extracts.

Study Overview
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Brief Summary
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The purpose of the study is to describe, over 6 weeks, the evolution of depressive symptoms in patients with mild to moderate major depression in a strategy with Phytostandard® Rhodiola-Saffron supplementation

Detailed Description
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For this study, 52 patients are going to be included. They will have a supplementation of Phytostandard® rhodiola/saffron, from 2 tablets per day during 42 days. on the one hand, during the two visits (inclusion and follow-up), the investigator completes the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression (CGI). During the inclusion visit, he completes with his patient CIM-10 for depression diagnostic. on the other hand, patients complete HAD 4 times : just after the inclusion visit, at day 14, at day 28 and just before the follow-up visit. He completes the Patient Global Impression too at each time.

Official Title
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Descriptive Study of a Phytotherapy Management Strategy for Mild to Moderate Major Depression With Phytostandard® Rhodiola-Saffron : a Combination of Rhodiola and Saffron Extracts.

Conditions
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Mild to Moderate Depression

Intervention / Treatment
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* Dietary Supplement: Phytostandard® Rhodiola-Saffron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suffering from mild to moderate depression as defined in CIM-10 Having a score on the HAM-D questionnaire between 8 and 18 Having agreed to participate at the study after being informed by the investigator Exclusion Criteria: Depressive patients already under medication or discontinuation of medication less than a month ago Patients with severe depression as defined in CIM-10 or HAM-D> 18 Patients considered at risk: attempted suicide or suicidal (observed by the investigator or Hamilton item 3 score> 2) Patients with psychiatric disorders: schizophrenia, bipolarity, addiction (drugs, alcohol ...), etc. Patient with severe disease (cancer, kidney or heart disease) or patient with a contra-indication for taking the product (patient under anti-hypertensive ...) Patients using agents containing piperine or St. John's wort (interactions) Pregnant or breastfeeding patients Patients who do not wish to complement Phytostandard® Rhodiola - Saffron. Patients who do not wish to participate in the study. Patients unable to understand the ins and outs of the study (mental incapacity, language barrier).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Phytostandard® Rhodiola-Saffron|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of HAM-D scale |  | between day 0 and day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of HAD patient scale |  | between day 0 and day 42 | 
| Evolution of CGI |  | between day 0 and day 42 | 
| Evolution of PGI |  | between day 0 and day 42 |