Rhodiola Rosea Therapy of Major Depressive Disorder
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/23/2018 |
| Start Date: | June 2010 |
| End Date: | July 2013 |
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.
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.
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.
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
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