Rhodiola Rosea Therapy of Major Depressive Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Herbal extract; Sertraline; Lactose monohydrate
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): 340-1,360 mg daily; 50-200 mg daily; 1-4 capsules daily
Other intervention name(s): Golden root; Zoloft; Milk powder
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Antidepressant Therapy; Herbal Treatment; Rhodiola rosea; Alternative Therapy