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

Mild to Moderate Depression Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981225
• Other study ID #: PiL-Obs-RSDep-015
• Status: Completed
• Start date: November 8, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: July 2018
• Source: Pileje
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 31, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Mild to Moderate Depression

Intervention

Dietary Supplement:
• Phytostandard® Rhodiola-Saffron

Locations

Country	Name	City	State
France	Pileje	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pileje

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of HAM-D scale		between day 0 and day 42
Secondary	Evolution of HAD patient scale		between day 0 and day 42
Secondary	Evolution of CGI		between day 0 and day 42
Secondary	Evolution of PGI		between day 0 and day 42