Rhodiola Rosea Therapy of Major Depressive Disorder

Completed · Phase 3

Conditions studied: Depression

In brief

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.

Key facts

Study ID: NCT01098318
Run by: University of Pennsylvania
People needed: 58
Starts: 2010-06-01
Expected to finish: 2013-07-01
Last updated by the study team: 2018-02-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Depression Research Unit — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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