Clinical trial NCT02981225: Management Strategy for Mild to Moderate Major Depression: Combination of Rhodiola and Saffron Extracts.
Official title: Descriptive Study of a Phytotherapy Management Strategy for Mild to Moderate Major Depression With Phytostandard® Rhodiola-Saffron : a Combination of Rhodiola and Saffron Extracts.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild to Moderate Depression
Lead sponsor: PiLeJe
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from mild to moderate depression

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Evolution of HAM-D scale
timeFrame: between day 0 and day 42
Secondary outcomes:
measure: Evolution of HAD patient scale
timeFrame: between day 0 and day 42
measure: Evolution of CGI
timeFrame: between day 0 and day 42
measure: Evolution of PGI
timeFrame: between day 0 and day 42
Other outcomes:
Locations:
city: Paris
country: France
facility: Pileje
Study officials:
References: