Rhodiola Rosea Therapy of Major Depressive Disorder

2014-08-27 03:14:46 | BioPortfolio


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.


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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment




Herbal extract, Sertraline, Lactose monohydrate


Depression Research Unit
United States


Not yet recruiting


University of Pennsylvania

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:46-0400

Clinical Trials [1648 Associated Clinical Trials listed on BioPortfolio]

Creatine Monohydrate Use for Preventing Altitude Induced Depression

This study involves the use of an investigational drug called Creatine Monohydrate. This means that the drug has not yet been approved by the Food & Drug Administration (FDA) for treatment...

Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.

Maintenance Study for Adolescent Depression

This study examined the benefit of continued treatment with an antidepressant medication, sertraline, in adolescents with depression who improved on sertraline acutely. We hypothesize tha...

Preventing Depression Recurrence in Diabetes

To study the effectiveness of sertraline (Zoloft) in treating depression in adults with diabetes. The study will also determine whether depressed diabetic patients who have successfully r...

A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety...

PubMed Articles [4492 Associated PubMed Articles listed on BioPortfolio]

Variability in the α and β anomer content of commercially available lactose.

Lactose, a disaccharide is a ubiquitous excipient in many pharmaceutical formulations which exists in two anomeric forms; either as α- or β-lactose. The anomers have different properties which can a...

A placebo controlled treatment trial of sertraline and interpersonal psychotherapy for postpartum depression.

The purpose of the present study was to test the efficacy of sertraline and Interpersonal Psychotherapy (IPT) relative to pill placebo in a two site randomized controlled trial over a period of 12 wee...

Sertraline-Induced Rhabdomyolysis, Trismus, and Cardiac Arrest in a Child.

Selective serotonin reuptake inhibitors are a commonly used and often effective class of medications in the treatment of mood disorders such as anxiety and depression. Sertraline (1S,4S-N-methyl-4-[3,...

Association between increased plasma levels of homocysteine and depression observed in individuals with primary lactose malabsorption.

Current literature proposes associations between homocysteine (HCY), folic acid (FA), vitamin B12 metabolism and depression. However, the exact underlying biological mechanisms remain unclear. This st...

Effect of lignin as natural polymer on the release rate of acetylsalicylic acid tablets.

The main focus here is on the improvement of formulations utilising non-conventional bio-based excipients to improve tablet release rates. Two different formulations were considered. The first formula...

Medical and Biotech [MESH] Definitions

A selective serotonin uptake inhibitor that is used in the treatment of depression.

The condition resulting from the absence or deficiency of LACTASE in the MUCOSA cells of the GASTROINTESTINAL TRACT, and the inability to break down LACTOSE in milk for ABSORPTION. Bacterial fermentation of the unabsorbed lactose leads to symptoms that range from a mild indigestion (DYSPEPSIA) to severe DIARRHEA. Lactose intolerance may be an inborn error or acquired.

A plant genus of the family POACEAE. Folin is the water-soluble extract from Sasa albomarginata. Sasa kurinensis is an ingredient of Sho-ju-sen, a Japanese herbal medicine.

Plasmids which determine the ability of a bacterium to ferment lactose.

A measure of a patient's ability to break down lactose.

More From BioPortfolio on "Rhodiola Rosea Therapy of Major Depressive Disorder"

Quick Search


Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Bipolar Disorders
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Over half of Bipolar cases develops before the age of 25. Bipolar ...

Searches Linking to this Trial