Rhodiola Rosea Therapy of Major Depressive Disorder

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Sertraline

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