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

P

PiLeJe

Status

Completed

Conditions

Mild to Moderate Depression

Treatments

Dietary Supplement: Phytostandard® Rhodiola-Saffron

Study type

Observational

Funder types

Industry

Identifiers

NCT02981225
PiL-Obs-RSDep-015

Details and patient eligibility

About

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

Full 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.

Enrollment

59 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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