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
|Condition or disease||Intervention/treatment||Phase|
|Depression||Dietary Supplement: Herbal extract Drug: Sertraline Other: Lactose monohydrate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Rhodiola Rosea Therapy of Major Depressive Disorder|
|Study Start Date :||June 2010|
|Primary Completion Date :||July 2013|
|Study Completion Date :||July 2013|
Experimental: Rhodiola rosea
Dietary Supplement: Herbal extract
340-1,360 mg daily
Other Name: Golden root
Active Comparator: Sertraline
50-200 mg daily
Other Name: Zoloft
Placebo Comparator: Sugar pill
Other: Lactose monohydrate
1-4 capsules daily
Other Name: Milk powder
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098318
|United States, Pennsylvania|
|Depression Research Unit|
|Philadelphia, Pennsylvania, United States, 19104-3309|
|Principal Investigator:||Jun J. Mao, MD||University of Pennsylvania|