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

Completed

• Conditions: Mild to Moderate Depression

• Registration Number: NCT02981225
• Lead Sponsor: PiLeJe

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.

Study Timeline

• Study Start: 2016-11-08
• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-31
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of HAM-D scale	between day 0 and day 42

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pileje; 🇫🇷 Paris, France