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

NCT02981225 | Completed

• 1 other identifier: PiL-Obs-RSDep-015
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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

Conditions

Mild to Moderate Depression

Outcome Measures

Primary Outcomes (1)

• Evolution of HAM-D scale

  between day 0 and day 42

Secondary Outcomes (3)

• 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

Interventions

Phytostandard® Rhodiola-Saffron DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from mild to moderate depression

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• PiLeJe: lead

Study Sites (1)

Pileje

Paris, 75015, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 5, 2016
• Study Start: November 8, 2016
• Primary Completion: May 30, 2017
• Study Completion: May 31, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

FR (1)