Phase 3
Completed N=57
Rhodiola Rosea Therapy of Major Depressive Disorder
Source: ClinicalTrials.gov NCT01098318 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12. — 8; 8.3; 8.9; 7.9 units on a scale
◆ Published Evidence
Highly cited
109citations · ~10 / year
Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial.
Summary
Prior research has shown that Rhodiola rosea may be an effective, short-term, anti-depressant therapy. This study will examine the anti-depressant effect of Rhodiola rosea vs. a conventional, anti-depressant drug in the treatment of major depression.
Linked Publications
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Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12. |
8; 8.3; 8.9; 7.9; 7.8; 8.5 | — |
| SECONDARY The Clinical Global Impression (CGI) Severity and Change |
9; 6; 7; 10; 7; 7 | — |
| SECONDARY Change in Depressive Symptoms as Measured by the Beck Depression Inventory |
-14.0; -13.7; -7.5 | — |
| SECONDARY Change in Sexual Function |
48; 36; 17; 49; 25.5; 12 | — |
| SECONDARY Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form |
6; 6; 9; 0; 0; 2 | — |
| SECONDARY Number of Participants With Treatment Emergent Side Effects |
6; 12; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women (all races and ethnicity) ≥ 18 years old
- DSM IV Axis I diagnosis of mild to moderate Major Depressive Disorder
- Baseline CGI/S rating of 3 ('mild') or 4 ('moderate')
- Baseline Hamilton Depression Rating score ≥ 10
- Not receiving other antidepressant therapy
- Able to provide signed informed consent
Exclusion Criteria
- Patients < 18 years old
- Current primary DSM IV Axis I diagnosis other than Major Depressive Disorder
- CGI/S rating of 5 ('marked'), 6 ('severe') or 7 ('very severe')
- Actively suicidal or requiring hospitalization
- Uncontrolled medical condition
- Pregnant or nursing women
- Women of child-bearing potential not using a medically acceptable form of contraception
- Concurrent use of herbal remedies or mineral supplements [Note: Use of mineral supplements prescribed for medical purposes (e.g., osteoporosis) will not be excluded]
- Current use of chemotherapy or other medication (e.g., interferon) known to produce fatigue or mood changes
- Known sensitivity to R. rosea or sertraline
- History of non-response to sertraline in the current depressive episode
Data sourced from ClinicalTrials.gov (NCT01098318) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.