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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Dietary Supplement: Herbal extract
Drug: Sertraline
Other: Lactose monohydrate
Enrollment 58
Recruitment Details There are actually 58 subjects who signed consents. However, one subject withdrew consent immediately after signed it due to change of mind. This subject didn't take any medication, therefore, only 57 subject received study intervention.
Pre-assignment Details  
Arm/Group Title Rhodiola Rosea Sertraline Sugar Pill
Hide Arm/Group Description

Herbal extract

Herbal extract: 340-1,360 mg daily

Conventional anti-depressant

Sertraline: 50-200 mg daily

Lactose monohydrate

Lactose monohydrate: 1-4 capsules daily

Period Title: Overall Study
Started 20 19 18
Completed 17 12 15
Not Completed 3 7 3
Arm/Group Title Rhodiola Rosea Sertraline Sugar Pill Total
Hide Arm/Group Description

Herbal extract

Herbal extract: 340-1,360 mg daily

Conventional anti-depressant

Sertraline: 50-200 mg daily

Lactose monohydrate

Lactose monohydrate: 1-4 capsules daily

Total of all reporting groups
Overall Number of Baseline Participants 20 19 18 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 18 participants 57 participants
46.9  (16.9) 41.4  (14.6) 46.7  (15.2) 45.0  (15.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 18 participants 57 participants
Female
8
  40.0%
10
  52.6%
8
  44.4%
26
  45.6%
Male
12
  60.0%
9
  47.4%
10
  55.6%
31
  54.4%
1.Primary Outcome
Title Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12.
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rhodiola Rosea Sertraline Sugar Pill
Hide Arm/Group Description:

Herbal extract

Herbal extract: 340-1,360 mg daily

Conventional anti-depressant

Sertraline: 50-200 mg daily

Lactose monohydrate

Lactose monohydrate: 1-4 capsules daily

Overall Number of Participants Analyzed 20 19 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
HAM-D17@WK8 8  (5.4) 8.3  (4.5) 8.9  (6.5)
HAM-D17@WK12 7.9  (6) 7.8  (4.3) 8.5  (6.7)
2.Secondary Outcome
Title The Clinical Global Impression (CGI) Severity and Change
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rhodiola Rosea Sertraline Sugar Pill
Hide Arm/Group Description:

Herbal extract

Herbal extract: 340-1,360 mg daily

Conventional anti-depressant

Sertraline: 50-200 mg daily

Lactose monohydrate

Lactose monohydrate: 1-4 capsules daily

Overall Number of Participants Analyzed 20 19 18
Measure Type: Count of Participants
Unit of Measure: Participants
WK12 CGI-Severity (Not ill and Borderline ill)
9
  45.0%
6
  31.6%
7
  38.9%
WK12 CGI-C (Much improved and very much improved)
10
  50.0%
7
  36.8%
7
  38.9%
3.Secondary Outcome
Title Change in Depressive Symptoms as Measured by the Beck Depression Inventory
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rhodiola Rosea Sertraline Sugar Pill
Hide Arm/Group Description:

Herbal extract

Herbal extract: 340-1,360 mg daily

Conventional anti-depressant

Sertraline: 50-200 mg daily

Lactose monohydrate

Lactose monohydrate: 1-4 capsules daily

Overall Number of Participants Analyzed 20 19 18
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-14.0  (10.0) -13.7  (5.1) -7.5  (12.2)
4.Secondary Outcome
Title Change in Sexual Function
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects were analyzed
Arm/Group Title Rhodiola Rosea Sertraline Sugar Pill
Hide Arm/Group Description:

Herbal extract

Herbal extract: 340-1,360 mg daily

Conventional anti-depressant

Sertraline: 50-200 mg daily

Lactose monohydrate

Lactose monohydrate: 1-4 capsules daily

Overall Number of Participants Analyzed 20 19 18
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
Baseline
48
(10 to 83)
36
(5 to 62)
17
(5 to 31)
WK12
49
(18 to 77)
25.5
(14 to 37)
12
(6 to 45)
5.Secondary Outcome
Title Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form
Hide Description Descriptive analysis of number of subjects in each treatment group who had suicidal ideation at baseline and WK12.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects were analyzed
Arm/Group Title Rhodiola Rosea Sertraline Sugar Pill
Hide Arm/Group Description:

Herbal extract

Herbal extract: 340-1,360 mg daily

Conventional anti-depressant

Sertraline: 50-200 mg daily

Lactose monohydrate

Lactose monohydrate: 1-4 capsules daily

Overall Number of Participants Analyzed 20 19 18
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline
6
  30.0%
6
  31.6%
9
  50.0%
WK12
0
   0.0%
0
   0.0%
2
  11.1%
6.Secondary Outcome
Title Number of Participants With Treatment Emergent Side Effects
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects were analyzed
Arm/Group Title Rhodiola Rosea Sertraline Sugar Pill
Hide Arm/Group Description:

Herbal extract

Herbal extract: 340-1,360 mg daily

Conventional anti-depressant

Sertraline: 50-200 mg daily

Lactose monohydrate

Lactose monohydrate: 1-4 capsules daily

Overall Number of Participants Analyzed 20 19 18
Measure Type: Count of Participants
Unit of Measure: Participants
6
  30.0%
12
  63.2%
3
  16.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rhodiola Rosea Sertraline Sugar Pill
Hide Arm/Group Description

Herbal extract

Herbal extract: 340-1,360 mg daily

Conventional anti-depressant

Sertraline: 50-200 mg daily

Lactose monohydrate

Lactose monohydrate: 1-4 capsules daily

All-Cause Mortality
Rhodiola Rosea Sertraline Sugar Pill
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rhodiola Rosea Sertraline Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/19 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rhodiola Rosea Sertraline Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/20 (30.00%)      12/19 (63.16%)      3/18 (16.67%)    
Gastrointestinal disorders       
Nausea *  1/20 (5.00%)  1 7/19 (36.84%)  10 1/18 (5.56%)  1
General disorders       
Sexual dysfunction *  1/20 (5.00%)  1 4/19 (21.05%)  7 0/18 (0.00%)  0
Dizziness *  2/20 (10.00%)  2 0/19 (0.00%)  0 0/18 (0.00%)  0
Psychiatric disorders       
Nervousness *  2/20 (10.00%)  2 2/19 (10.53%)  2 2/18 (11.11%)  2
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jun Mao, Associate Professor
Organization: University of Pennsylvania
Phone: 215-746-2481
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01098318     History of Changes
Other Study ID Numbers: AT005230
R21AT005230 ( U.S. NIH Grant/Contract )
First Submitted: April 1, 2010
First Posted: April 2, 2010
Results First Submitted: July 20, 2015
Results First Posted: May 18, 2016
Last Update Posted: February 21, 2018