Rhodiola Rosea Therapy of Major Depressive Disorder

NCT ID: NCT01098318

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-07-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Rhodiola rosea

Herbal extract

Group Type: EXPERIMENTAL

Herbal extract

Intervention Type: DIETARY_SUPPLEMENT

340-1,360 mg daily

Sertraline

Conventional anti-depressant

Group Type: ACTIVE_COMPARATOR

Sertraline

Intervention Type: DRUG

50-200 mg daily

Sugar pill

Lactose monohydrate

Group Type: PLACEBO_COMPARATOR

Lactose monohydrate

Intervention Type: OTHER

1-4 capsules daily

Interventions

Herbal extract

340-1,360 mg daily

Intervention Type: DIETARY_SUPPLEMENT

Sertraline

50-200 mg daily

Intervention Type: DRUG

Lactose monohydrate

1-4 capsules daily

Intervention Type: OTHER

Other Intervention Names

Golden root; Zoloft; Milk powder

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun J. Mao, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Depression Research Unit

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25837277 (View on PubMed)

Related Links

http://www.med.upenn.edu/psychiatry/programs.html

Depression Research Unit-Department of Psychiatry Clinical Research Programs

Other Identifiers

R21AT005230

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AT005230

Identifier Type: -

Identifier Source: org_study_id