Mild to Moderate Depression
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTPhytostandard® Rhodiola-Saffron
Sponsors
PiLeJe
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of HAM-D scale | between day 0 and day 42 |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed