We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

Rhodiola Rosea Therapy of Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01098318
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : May 18, 2016
Last Update Posted : February 22, 2018
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Depression Dietary Supplement: Herbal extract Drug: Sertraline Other: Lactose monohydrate Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rhodiola Rosea Therapy of Major Depressive Disorder
Study Start Date : June 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rhodiola rosea
Herbal extract
Dietary Supplement: Herbal extract
340-1,360 mg daily
Other Name: Golden root

Active Comparator: Sertraline
Conventional anti-depressant
Drug: Sertraline
50-200 mg daily
Other Name: Zoloft

Placebo Comparator: Sugar pill
Lactose monohydrate
Other: Lactose monohydrate
1-4 capsules daily
Other Name: Milk powder

Primary Outcome Measures :
  1. Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12. [ Time Frame: 12 weeks ]
    Hamilton Depression Rating Scale (HAM-D) is a validated, clinician-rated instrument for ascertaining the severity of MDD symptoms. The 28-item Hamilton Depression Rating Scale was used to determine the primary outcome of 17-item HAM-D score. The HAM-D will serves as the primary outcome measure. HAM-D17 score ranges from 0 to 68. Higher score indicates more depressed symptom.

Secondary Outcome Measures :
  1. The Clinical Global Impression (CGI) Severity and Change [ Time Frame: 12 weeks ]
    A clinician-rated measure of global symptom severity (CGI/S) and symptom change (CGI/C) of MDD. Severity was rated as "Not ill"; "Borderline ill"; "Mild"; "Moderate"; "Moderately severe"; "Severe" and "Extremely severe". Global change was rates as "Very much improved"; "Much improved"; "Minimally improved"; "Unchanged";"Minimally worse";"Much worse" and "Very much worse". Here in severity, we reported the N(%) of subjects who were not ill or borderline ill. In change, we reported N(%) of subjects who were "Very much improved" or "Much imp[roved".Subjects started the study with mild to moderate MDD (moderate or above rating in the CGI-S). At WK12, the #/% of subjects in each treatment group who were not ill at WK12 (CGI-S) and who had much improved or very much improved at WK12 (CGI-C) was reported.

  2. Change in Depressive Symptoms as Measured by the Beck Depression Inventory [ Time Frame: 12 weeks ]
    All enrolled subjects were analyzed. Mean change in Beck Depression Inventory (BDI) total scores were reported. BDI is a self-reported outcome measuring the severity of depression. A negative # means a reduction in BDI score at the end of treatment compared to baseline which represents an improvement in depression symptoms. BDI total score ranges from 0-63. BDI score of 1-16 represents low level of depression;17-30 represents moderate level of depression; >=31 represents significant level of depression. A reduction in the BDI score represents improvement in the depression symptoms.

  3. Change in Sexual Function [ Time Frame: 12 weeks ]
    This is a patient completed rating of sexual function and satisfaction. It is used to assess current sexual health and changes in sexual health over time measured by the overall sexual satisfaction score. The reported score is the overall degree of sexual satisfaction attained. The score ranges from 0 to 100. Higher score indicates more sexual satisfaction.

  4. Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form [ Time Frame: 12 weeks ]
    Descriptive analysis of number of subjects in each treatment group who had suicidal ideation at baseline and WK12.

  5. Number of Participants With Treatment Emergent Side Effects [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098318

Layout table for location information
United States, Pennsylvania
Depression Research Unit
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
University of Pennsylvania
National Center for Complementary and Integrative Health (NCCIH)
Layout table for investigator information
Principal Investigator: Jun J. Mao, MD University of Pennsylvania
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01098318    
Other Study ID Numbers: AT005230
R21AT005230 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2010    Key Record Dates
Results First Posted: May 18, 2016
Last Update Posted: February 22, 2018
Last Verified: January 2018
Keywords provided by University of Pennsylvania:
Antidepressant Therapy
Herbal Treatment
Rhodiola rosea
Alternative Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs