Psychological Well-being
Conditions
Brief summary
The objective of the study is to compare the effect of a 6-week supplementation with a dietary supplement based on plant extracts to the effect of placebo, in patients with a moderate depressive episode (F32.1 by ICD10 definition) and with moderate symptoms (score HAM-D ≥ 16 and ≤ 23).
Detailed description
Longitudinal, comparative, randomized, placebo-controlled interventional study in 2 parallel groups, double-blind, monocentre, aimed at demonstrating the superiority of the combination of plants over placebo on depressive symptoms. Each patient will be followed for a maximum of 6 weeks, with 3 visits to the doctor.
Interventions
DIETARY_SUPPLEMENTDietary supplement
Dietary supplement under study is based on Rhodiola rosea L. and Crocus sativus L. extracts
OTHERPlacebo
Placebo of the dietary supplement
Sponsors
Université Catholique de Louvain
Larena SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 and ≤ 75 years old ; * Patient with a moderate depressive episode (F32.1 by ICD10 definition) ; * Score HAM-D ≥ 16 and ≤ 23 at inclusion, corresponding to moderate symptoms ; * Recent depression (less than 6 months), not managed by antidepressant or psychotherapeutic treatment ; * Depressive disorder not requiring, in the opinion of the investigator, initiation of antidepressant drug therapy ; * Patient able to understand the study information, read the information leaflet, and willing to sign the consent form ; * French speaking patient.
Exclusion criteria
* Patient with a depressive disorder of another nature or any other mental illness (schizophrenia, bipolarity, alcohol or drug addiction, etc.); * Patient at risk of suicide (noted by the investigator, or HAM-D item 3 score \> 2) or having attempted suicide in the last 5 years; * Depression felt for more than 6 months ; * Patient under psychotropic treatment (current or in the month preceding inclusion) (neuroleptic, anxiolytic, hypnotic); * Patient on beta-blocker therapy ; * Patient on dialysis ; * Patient using products containing piperine or St. John's wort, or having a known effect on mood in the last 30 days ; * Woman who is pregnant or breastfeeding, or has plans to become pregnant in the next 8 weeks ; * Patient with an allergy or contraindication to one of the components of the product under study (rhodiola or saffron) ; * Patient unable to understand information related to the study (mental or linguistic disability) ; * Patient participating or having participated in the previous 3 months in another clinical trial ;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of depressive symptoms through Hamilton Depression Scale (HAM-D) at the end of the study | 42 days | Score HAM-D at D42, adjusted to the value at D0 minimum = 0 and maximum = 53 higher score means a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of depressive symptoms through HAM-D during the study | 42 days | Evolution of score HAM-D between D0, D21 and D42 |
| Evolution of depressive symptoms through HAM-D sub-scores during the study | 42 days | Evolution of sub-scores HAM-D between D0, D21 and D42 |
| Rate of responding participants (decrease of ≥ 3 points) at D21 | 21 days | HAM-D score showing a decrease of ≥ 3 points compared to D0 |
| Rate of responding participants (decrease of ≥ 3 points) at D42 | 42 days | HAM-D score showing a decrease of ≥ 3 points compared to D0 |
| Rate of responding participants (decrease of ≥ 5 points) at D21 | 21 days | HAM-D score showing a decrease of ≥ 5 points compared to D0 |
| Rate of responding participants (decrease of ≥ 5 points) at D42 | 42 days | HAM-D score showing a decrease of ≥ 5 points compared to D0 |
| Rate of participants in remission at D21 | 21 days | score HAM-D ≤ 7 |
| Rate of participants in remission at D42 | 42 days | score HAM-D ≤ 7 |
| Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Depression (HADS-D) during the study | 42 days | Evolution of sub-scores HADS-D between D0, D21 and D42 minimum = 0 and maximum = 21 higher score means a worse outcome |
| Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Anxiety (HADS-A) during the study | 42 days | Evolution of sub-scores HADS-A between D0, D21 and D42 minimum = 0 and maximum = 21 higher score means a worse outcome |
| Adverse events | 42 days | Number and type of adverse events |
| Evolution of physician's general impression of the symptoms evolution during the study | 42 days | Evolution of Clinical Global Impression-Improvement (CGI-I) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome |
| Evolution of patient's general impression of the symptoms evolution during the study | 42 days | Evolution of Patient Global Impression-Improvement (PGI-I) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome |
| Evolution of patient's functional disability in his or her professional, social and family life during the study | 42 days | Evolution of Sheehan Disability Score (SDS) between D0, D21 and D42 minimum = 0 and maximum = 44 higher score means a worse outcome |
| Patient satisfaction with complementation at D21 | 21 days | 5-point Likert scale (minimum = 1 and maximum = 5) higher score means a better satisfaction |
| Patient satisfaction with complementation at D42 | 42 days | 5-point Likert scale |
| Number of intercurrent visits | 42 days | Number of intercurrent visits |
| Concomitant drug use | 42 days | Number and type of concomitant drugs |
| Compliance at D21 | 21 days | Counting of therapeutic units at D21 |
| Compliance at D42 | 42 days | Counting of therapeutic units at D42 |
| Management prescribed or advised at the end of follow-up | 42 days | Rate of participants on the same dietary supplement, antidepressant medication, other or without treatment at the end of the study |
| Evolution of physician's general impression of the symptoms during the study | 42 days | Evolution of Clinical Global Impression-Severity (CGI-S) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome |
Countries
Belgium
Outcome results
None listed