Clinical trial NCT01098318: Rhodiola Rosea Therapy of Major Depressive Disorder
Official title: Rhodiola Rosea Therapy of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Depression
Antidepressant Therapy
Herbal Treatment
Rhodiola rosea
Alternative Therapy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-04-02
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: We will study the antidepressant action of R. rosea in patients with MDD. Depression affects more than a billion people world wide, and is now recognized as one of the most disabling medical conditions. It accounts for more than 11% of the total disease burden worldwide, and can result in devastating consequences and functional impairment exceeded only by that of cancer and cardiovascular disease. It results in substantial social, occupational, and personal disability and in increased medical co-morbidity and death by suicide. It is considered to be a multi-systemic disorder characterized by neurotransmitter, neuroendocrine, immunologic, and autonomic, and infectious disturbances. Although the development of antidepressant drug therapy has simplified the treatment of MDD, a substantial segment of the world's population remains untreated for economic, cultural, or personal reasons. As a result, many individuals seek CAM for relief of their symptoms. The identification of effective CAM therapies for MDD is of public health relevance. R. rosea belongs to the family Crassulaceae, and has a long history as a folk remedy for enhancing physical and emotional endurance. Its adaptogen, or preventive, properties have also led to its use in treating cancer, infection, depression, and other nervous system disorders. Several animal and human studies suggest that R. rosea may have antidepressant properties. For specific aim #1, we will ask: Is R. rosea a safe and effective short-term therapy (vs. sertraline and placebo) for patients with MDD?" To answer this question, patients meeting DSM IV criteria for mild to moderate MDD will be enrolled in a 12-week, randomized, double-blind, placebo-controlled, parallel group, dose-escalation study of R. rosea extract 340-1,360 mg daily vs. sertraline 50-200 mg daily. The primary outcome measure will be change over time in the 17-item Hamilton Depression Rating score. We hypothesize that R. rosea will have superior efficacy vs. placebo and comparable efficacy vs. sertraline. For specific aim #2, we will ask: Does R. rosea therapy result in a favorable tolerability and quality of life (QOL) profile vs. sertraline and placebo? To answer this question, we will obtain safety and QOL measures across treatment conditions that include: (i) frequency, duration, and severity of adverse events, (ii) frequency of serious adverse events, (iii) frequency of dosage reduction, (iv) frequency of treatment discontinuation, and (v) QOL and sexual performance measures. We hypothesize that R. rosea will have a superior tolerability profile vs. sertraline, and similar tolerability vs. placebo. We further hypothesize that R. rosea will have superior QOL and sexual performance ratings vs. sertraline and placebo. Results from this study will be used to inform future research hypotheses and to estimate the effect size necessary to power a future, large scale study.

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

Primary outcomes:
measure: Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12.
timeFrame: 12 weeks
Secondary outcomes:
measure: The Clinical Global Impression (CGI) Severity and Change
timeFrame: 12 weeks
measure: Change in Depressive Symptoms as Measured by the Beck Depression Inventory
timeFrame: 12 weeks
measure: Change in Sexual Function
timeFrame: 12 weeks
measure: Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form
timeFrame: 12 weeks
measure: Number of Participants With Treatment Emergent Side Effects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Depression Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jun J. Mao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mao JJ, Xie SX, Zee J, Soeller I, Li QS, Rockwell K, Amsterdam JD. Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial. Phytomedicine. 2015 Mar 15;22(3):394-9. doi: 10.1016/j.phymed.2015.01.010. Epub 2015 Feb 23.