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| Name | Class |
|---|---|
| Université Catholique de Louvain | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement group | Experimental | 2 tablets / day for 6 weeks of the dietary supplement (Rhodiola rosea L. and Crocus sativus L.), to be taken every day in the morning with a large glass of water, from D1 to D42. |
|
| Placebo group | Placebo Comparator | 2 tablets / day for 6 weeks of the placebo, to be taken every day in the morning with a large glass of water, from D1 to D42. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement | Dietary Supplement | Dietary supplement under study is based on Rhodiola rosea L. and Crocus sativus L. extracts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of depressive symptoms through Hamilton Depression Scale (HAM-D) at the end of the study | Score HAM-D at D42, adjusted to the value at D0 minimum = 0 and maximum = 53 higher score means a worse outcome | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of depressive symptoms through HAM-D during the study | Evolution of score HAM-D between D0, D21 and D42 | 42 days |
| Evolution of depressive symptoms through HAM-D sub-scores during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CICN - Université Catholique de Louvain | Louvain-la-Neuve | Belgium |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo | Other | Placebo of the dietary supplement |
|
Evolution of sub-scores HAM-D between D0, D21 and D42
| 42 days |
| Rate of responding participants (decrease of ≥ 3 points) at D21 | HAM-D score showing a decrease of ≥ 3 points compared to D0 | 21 days |
| Rate of responding participants (decrease of ≥ 3 points) at D42 | HAM-D score showing a decrease of ≥ 3 points compared to D0 | 42 days |
| Rate of responding participants (decrease of ≥ 5 points) at D21 | HAM-D score showing a decrease of ≥ 5 points compared to D0 | 21 days |
| Rate of responding participants (decrease of ≥ 5 points) at D42 | HAM-D score showing a decrease of ≥ 5 points compared to D0 | 42 days |
| Rate of participants in remission at D21 | score HAM-D ≤ 7 | 21 days |
| Rate of participants in remission at D42 | score HAM-D ≤ 7 | 42 days |
| Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Depression (HADS-D) during the study | Evolution of sub-scores HADS-D between D0, D21 and D42 minimum = 0 and maximum = 21 higher score means a worse outcome | 42 days |
| Evolution of depressive symptoms through Hospital Anxiety and Depression Scale - Anxiety (HADS-A) during the study | Evolution of sub-scores HADS-A between D0, D21 and D42 minimum = 0 and maximum = 21 higher score means a worse outcome | 42 days |
| Evolution of physician's general impression of the symptoms during the study | Evolution of Clinical Global Impression-Severity (CGI-S) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome | 42 days |
| Evolution of physician's general impression of the symptoms evolution during the study | Evolution of Clinical Global Impression-Improvement (CGI-I) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome | 42 days |
| Evolution of patient's general impression of the symptoms evolution during the study | Evolution of Patient Global Impression-Improvement (PGI-I) between D0, D21 and D42 minimum = 1 and maximum = 7 higher score means a worse outcome | 42 days |
| Adverse events | Number and type of adverse events | 42 days |
| Evolution of patient's functional disability in his or her professional, social and family life during the study | Evolution of Sheehan Disability Score (SDS) between D0, D21 and D42 minimum = 0 and maximum = 44 higher score means a worse outcome | 42 days |
| Patient satisfaction with complementation at D21 | 5-point Likert scale (minimum = 1 and maximum = 5) higher score means a better satisfaction | 21 days |
| Patient satisfaction with complementation at D42 | 5-point Likert scale | 42 days |
| Number of intercurrent visits | Number of intercurrent visits | 42 days |
| Concomitant drug use | Number and type of concomitant drugs | 42 days |
| Compliance at D21 | Counting of therapeutic units at D21 | 21 days |
| Compliance at D42 | Counting of therapeutic units at D42 | 42 days |
| Management prescribed or advised at the end of follow-up | Rate of participants on the same dietary supplement, antidepressant medication, other or without treatment at the end of the study | 42 days |