Rhodiola Rosea Therapy of Major Depressive Disorder

NCT01098318 | Completed Phase 3 Results DMC

• 2 other identifiers: AT005230R21AT005230
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Depression; Antidepressant Therapy; Herbal Treatment; Rhodiola rosea; Alternative Therapy

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12.

  Hamilton Depression Rating Scale (HAM-D) is a validated, clinician-rated instrument for ascertaining the severity of MDD symptoms. The 28-item Hamilton Depression Rating Scale was used to determine the primary outcome of 17-item HAM-D score. The HAM-D will serves as the primary outcome measure. HAM-D17 score ranges from 0 to 68. Higher score indicates more depressed symptom.

  12 weeks

Secondary Outcomes (5)

• The Clinical Global Impression (CGI) Severity and Change

  12 weeks

• Change in Depressive Symptoms as Measured by the Beck Depression Inventory

  12 weeks

• Change in Sexual Function

  12 weeks

• Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form

  12 weeks

• Number of Participants With Treatment Emergent Side Effects

  12 weeks

Study Arms (3)

Rhodiola rosea

EXPERIMENTAL

Herbal extract

Dietary Supplement: Herbal extract

Sertraline

ACTIVE COMPARATOR

Conventional anti-depressant

Drug: Sertraline

Sugar pill

PLACEBO COMPARATOR

Lactose monohydrate

Other: Lactose monohydrate

Interventions

Herbal extract DIETARY_SUPPLEMENT

340-1,360 mg daily

Also known as: Golden root

Rhodiola rosea

Sertraline DRUG

50-200 mg daily

Also known as: Zoloft

Sertraline

Lactose monohydrate OTHER

1-4 capsules daily

Also known as: Milk powder

Sugar pill

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Depression Research Unit

Philadelphia, Pennsylvania, 19104-3309, United States

Location

Related Publications (1)

• Mao JJ, Xie SX, Zee J, Soeller I, Li QS, Rockwell K, Amsterdam JD. Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial. Phytomedicine. 2015 Mar 15;22(3):394-9. doi: 10.1016/j.phymed.2015.01.010. Epub 2015 Feb 23.

  PMID: 25837277 DERIVED

Related Links

• Depression Research Unit-Department of Psychiatry Clinical Research Programs

MeSH Terms

Conditions

Depression

Interventions

Sertraline; Refit milk powder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Subjects refuse to answer measures such as the RUSH sexual inventory and the CSSR. Therefore, no statistical analysis was performed on these. In addition, suicidal ideation (measured by CSSR) was captured in the AE form during the study peiod.

Results Point of Contact

• Title: Dr. Jun Mao, Associate Professor
• Organization: University of Pennsylvania

jun.mao@uphs.upenn.edu

215-746-2481

Study Officials

• Jun J. Mao, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 22, 2018
• Results First Posted: May 18, 2016

Record last verified: 2018-01

Locations

US (1)