Mild to Moderate DepressionNCT02981225
Management Strategy for Mild to Moderate Major Depression: Combination of Rhodiola and Saffron Extracts.
An observational study of Mild to Moderate Depression, run by PiLeJe at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mild to Moderate Depression
- What is being tested?
- Phytostandard® Rhodiola-Saffron
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2016to 31 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from mild to moderate depression
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
Official 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.
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
Read the 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.
- Conditions
- Mild to Moderate Depression
- Being tested
- Phytostandard® Rhodiola-Saffron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phytostandard® Rhodiola-SaffronDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of HAM-D scale
Measured: between day 0 and day 42
Secondary outcomes (3)
Evolution of HAD patient scale
Measured: between day 0 and day 42
Evolution of CGI
Measured: between day 0 and day 42
Evolution of PGI
Measured: between day 0 and day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start8 Nov 2016
- Primary completion30 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981225
- Sponsor's protocol ID
- PiL-Obs-RSDep-015
- Status last verified
- Jul 2018
- First submitted
- 24 Nov 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT02981225
- Acronym / sponsor ID
- PiL-Obs-RSDep-015
- Conditions
- Mild to Moderate Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from mild to moderate depression
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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 ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phytostandard® Rhodiola-Saffron | Dietary supplement | – |
Primary outcome
Evolution of HAM-D scale
Time frame: between day 0 and day 42
3 secondary outcomes
Evolution of HAD patient scale
Time frame: between day 0 and day 42
Evolution of CGI
Time frame: between day 0 and day 42
Evolution of PGI
Time frame: between day 0 and day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild to Moderate Depression, run by PiLeJe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of HAM-D scale (time frame: between day 0 and day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.