Management Strategy for Mild to Moderate Major Depression... | NCT02981225

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

NCT02981225

Sponsor

PiLeJe

Status

Completed

Last Update Posted

Jul 17, 2018Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Mild to Moderate Depression

Interventions

Phytostandard® Rhodiola-Saffron

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2016Actual

Primary Completion Date

May 30, 2017Actual

Completion Date

May 31, 2017Actual

First Submitted Date

Nov 24, 2016

First Submission Date that Met QC Criteria

Nov 30, 2016

First Posted Date

Dec 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2018

Last Update Posted Date

Jul 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Name	Type	Description	Arm Group Labels	Other Names
Phytostandard® Rhodiola-Saffron	Dietary Supplement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from mild to moderate depression

Sampling Method

Probability Sample