NCT02981225

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: PiLeJe · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild to Moderate Depression

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Phytostandard® Rhodiola-Saffron

Timeline

• Start date: 2016-11-08
• Primary completion: 2017-05-30
• Completion: 2017-05-31
• First posted: 2016-12-05
• Last updated: 2018-07-17

Locations

1 site across 1 country: France