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

July 13, 2018 updated by: PiLeJe

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • PiLeJe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suffering from mild to moderate depression

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution of HAM-D scale
Time Frame: between day 0 and day 42
between day 0 and day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Evolution of HAD patient scale
Time Frame: between day 0 and day 42
between day 0 and day 42
Evolution of CGI
Time Frame: between day 0 and day 42
between day 0 and day 42
Evolution of PGI
Time Frame: between day 0 and day 42
between day 0 and day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PiLeJe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2016

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PiL-Obs-RSDep-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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