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Trial record 48 of 1076 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

Rhodiola Rosea Therapy of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01098318
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : May 18, 2016
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE April 1, 2010
First Posted Date  ICMJE April 2, 2010
Results First Submitted Date  ICMJE July 20, 2015
Results First Posted Date  ICMJE May 18, 2016
Last Update Posted Date February 21, 2018
Study Start Date  ICMJE June 2010
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2016)
Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12. [ Time Frame: 12 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
Reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale. [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01098318 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
  • The Clinical Global Impression (CGI) Severity and Change [ Time Frame: 12 weeks ]
    A clinician-rated measure of global symptom severity (CGI/S) and symptom change (CGI/C) of MDD. Severity was rated as "Not ill"; "Borderline ill"; "Mild"; "Moderate"; "Moderately severe"; "Severe" and "Extremely severe". Global change was rates as "Very much improved"; "Much improved"; "Minimally improved"; "Unchanged";"Minimally worse";"Much worse" and "Very much worse". Here in severity, we reported the N(%) of subjects who were not ill or borderline ill. In change, we reported N(%) of subjects who were "Very much improved" or "Much imp[roved".Subjects started the study with mild to moderate MDD (moderate or above rating in the CGI-S). At WK12, the #/% of subjects in each treatment group who were not ill at WK12 (CGI-S) and who had much improved or very much improved at WK12 (CGI-C) was reported.
  • Change in Depressive Symptoms as Measured by the Beck Depression Inventory [ Time Frame: 12 weeks ]
    All enrolled subjects were analyzed. Mean change in Beck Depression Inventory (BDI) total scores were reported. BDI is a self-reported outcome measuring the severity of depression. A negative # means a reduction in BDI score at the end of treatment compared to baseline which represents an improvement in depression symptoms. BDI total score ranges from 0-63. BDI score of 1-16 represents low level of depression;17-30 represents moderate level of depression; >=31 represents significant level of depression. A reduction in the BDI score represents improvement in the depression symptoms.
  • Change in Sexual Function [ Time Frame: 12 weeks ]
    This is a patient completed rating of sexual function and satisfaction. It is used to assess current sexual health and changes in sexual health over time measured by the overall sexual satisfaction score. The reported score is the overall degree of sexual satisfaction attained. The score ranges from 0 to 100. Higher score indicates more sexual satisfaction.
  • Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form [ Time Frame: 12 weeks ]
    Descriptive analysis of number of subjects in each treatment group who had suicidal ideation at baseline and WK12.
  • Number of Participants With Treatment Emergent Side Effects [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
  • The Clinical Global Impression (CGI) Severity and Change Ratings Will be Secondary Outcome Measures. [ Time Frame: 12 weeks ]
  • Reduction in Depressive Symptoms as Measured by the Beck Depression Inventory Will be a Secondary Outcome Measure. [ Time Frame: 12 weeks ]
  • Change in Sexual Function Will be a Secondary Outcome Measure. [ Time Frame: 12 weeks ]
  • Change in Suicide Ideation as Determined by the Columbia Suicide Form Will be a Secondary Outcome Measure. [ Time Frame: 12 weeks ]
  • Treatment Emergent Side Effects Scale Will be Used to Assess Treatment-related Side Effects as a Secondary Outcome Measure. [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rhodiola Rosea Therapy of Major Depressive Disorder
Official Title  ICMJE Rhodiola Rosea Therapy of Major Depressive Disorder
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.
Detailed Description 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Dietary Supplement: Herbal extract
    340-1,360 mg daily
    Other Name: Golden root
  • Drug: Sertraline
    50-200 mg daily
    Other Name: Zoloft
  • Other: Lactose monohydrate
    1-4 capsules daily
    Other Name: Milk powder
Study Arms  ICMJE
  • Experimental: Rhodiola rosea
    Herbal extract
    Intervention: Dietary Supplement: Herbal extract
  • Active Comparator: Sertraline
    Conventional anti-depressant
    Intervention: Drug: Sertraline
  • Placebo Comparator: Sugar pill
    Lactose monohydrate
    Intervention: Other: Lactose monohydrate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2014)
58
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2010)
48
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01098318
Other Study ID Numbers  ICMJE AT005230
R21AT005230 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Jun J. Mao, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP