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Completed

NCT Number: NCT02981225

Management Strategy for Mild to Moderate Major Depression: 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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pileje

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Phytostandard® Rhodiola-Saffron

Dietary Supplement

Primary outcomes

  1. Evolution of HAM-D scale

    Time frame: between day 0 and day 42

Secondary outcomes

  1. Evolution of HAD patient scale

    Time frame: between day 0 and day 42

  2. Evolution of CGI

    Time frame: between day 0 and day 42

  3. Evolution of PGI

    Time frame: between day 0 and day 42

Sponsors and collaborators

Lead sponsor

PiLeJe

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2016
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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