Rhodiola Rosea Therapy of Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jun Mao, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01098318
First received: April 1, 2010
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Depression
Dietary Supplement: Herbal extract
Drug: Sertraline
Other: Lactose monohydrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rhodiola Rosea Therapy of Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Clinical Global Impression (CGI) Severity and Change ratings will be secondary outcome measures. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Reduction in depressive symptoms as measured by the Beck Depression Inventory will be a secondary outcome measure. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in sexual function will be a secondary outcome measure. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in suicide ideation as determined by the Columbia Suicide Form will be a secondary outcome measure. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Treatment Emergent Side Effects Scale will be used to assess treatment-related side effects as a secondary outcome measure. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: June 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098318

Locations
United States, Pennsylvania
Depression Research Unit
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Jun J. Mao, MD University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Jun Mao, Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01098318     History of Changes
Other Study ID Numbers: AT005230, R21 AT005230
Study First Received: April 1, 2010
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Depression
Antidepressant Therapy
Herbal Treatment
Rhodiola rosea
Alternative Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Sertraline
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014