Trial Outcomes & Findings for Rhodiola Rosea Therapy of Major Depressive Disorder (NCT NCT01098318)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

58 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-02-22

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Rhodiola Rosea Herbal extract Herbal extract: 340-1,360 mg daily	Sertraline Conventional anti-depressant Sertraline: 50-200 mg daily	Sugar Pill Lactose monohydrate Lactose monohydrate: 1-4 capsules daily
Overall Study STARTED	20	19	18
Overall Study COMPLETED	17	12	15
Overall Study NOT COMPLETED	3	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rhodiola Rosea Therapy of Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rhodiola Rosea n=20 Participants Herbal extract Herbal extract: 340-1,360 mg daily	Sertraline n=19 Participants Conventional anti-depressant Sertraline: 50-200 mg daily	Sugar Pill n=18 Participants Lactose monohydrate Lactose monohydrate: 1-4 capsules daily	Total n=57 Participants Total of all reporting groups
Age, Continuous	46.9 years STANDARD_DEVIATION 16.9 • n=5 Participants	41.4 years STANDARD_DEVIATION 14.6 • n=7 Participants	46.7 years STANDARD_DEVIATION 15.2 • n=5 Participants	45.0 years STANDARD_DEVIATION 15.5 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rhodiola Rosea n=20 Participants Herbal extract Herbal extract: 340-1,360 mg daily	Sertraline n=19 Participants Conventional anti-depressant Sertraline: 50-200 mg daily	Sugar Pill n=18 Participants Lactose monohydrate Lactose monohydrate: 1-4 capsules daily
Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12. HAM-D17@WK8	8 units on a scale Standard Deviation 5.4	8.3 units on a scale Standard Deviation 4.5	8.9 units on a scale Standard Deviation 6.5
Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12. HAM-D17@WK12	7.9 units on a scale Standard Deviation 6	7.8 units on a scale Standard Deviation 4.3	8.5 units on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rhodiola Rosea n=20 Participants Herbal extract Herbal extract: 340-1,360 mg daily	Sertraline n=19 Participants Conventional anti-depressant Sertraline: 50-200 mg daily	Sugar Pill n=18 Participants Lactose monohydrate Lactose monohydrate: 1-4 capsules daily
The Clinical Global Impression (CGI) Severity and Change WK12 CGI-Severity (Not ill and Borderline ill)	9 Participants	6 Participants	7 Participants
The Clinical Global Impression (CGI) Severity and Change WK12 CGI-C (Much improved and very much improved)	10 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rhodiola Rosea n=20 Participants Herbal extract Herbal extract: 340-1,360 mg daily	Sertraline n=19 Participants Conventional anti-depressant Sertraline: 50-200 mg daily	Sugar Pill n=18 Participants Lactose monohydrate Lactose monohydrate: 1-4 capsules daily
Change in Depressive Symptoms as Measured by the Beck Depression Inventory	-14.0 scores on a scale Standard Deviation 10.0	-13.7 scores on a scale Standard Deviation 5.1	-7.5 scores on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: 12 weeks

Population: All enrolled subjects were analyzed

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.

Outcome measures

Outcome measures
Measure	Rhodiola Rosea n=20 Participants Herbal extract Herbal extract: 340-1,360 mg daily	Sertraline n=19 Participants Conventional anti-depressant Sertraline: 50-200 mg daily	Sugar Pill n=18 Participants Lactose monohydrate Lactose monohydrate: 1-4 capsules daily
Change in Sexual Function Baseline	48 scores on a scale Interval 10.0 to 83.0	36 scores on a scale Interval 5.0 to 62.0	17 scores on a scale Interval 5.0 to 31.0
Change in Sexual Function WK12	49 scores on a scale Interval 18.0 to 77.0	25.5 scores on a scale Interval 14.0 to 37.0	12 scores on a scale Interval 6.0 to 45.0

SECONDARY outcome

Timeframe: 12 weeks

Population: All enrolled subjects were analyzed

Descriptive analysis of number of subjects in each treatment group who had suicidal ideation at baseline and WK12.

Outcome measures

Outcome measures
Measure	Rhodiola Rosea n=20 Participants Herbal extract Herbal extract: 340-1,360 mg daily	Sertraline n=19 Participants Conventional anti-depressant Sertraline: 50-200 mg daily	Sugar Pill n=18 Participants Lactose monohydrate Lactose monohydrate: 1-4 capsules daily
Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form Baseline	6 Participants	6 Participants	9 Participants
Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form WK12	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: All enrolled subjects were analyzed

Outcome measures

Outcome measures
Measure	Rhodiola Rosea n=20 Participants Herbal extract Herbal extract: 340-1,360 mg daily	Sertraline n=19 Participants Conventional anti-depressant Sertraline: 50-200 mg daily	Sugar Pill n=18 Participants Lactose monohydrate Lactose monohydrate: 1-4 capsules daily
Number of Participants With Treatment Emergent Side Effects	6 Participants	12 Participants	3 Participants

Adverse Events

Rhodiola Rosea

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Sertraline

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rhodiola Rosea n=20 participants at risk Herbal extract Herbal extract: 340-1,360 mg daily	Sertraline n=19 participants at risk Conventional anti-depressant Sertraline: 50-200 mg daily	Sugar Pill n=18 participants at risk Lactose monohydrate Lactose monohydrate: 1-4 capsules daily
General disorders Sexual dysfunction	5.0% 1/20 • Number of events 1	21.1% 4/19 • Number of events 7	0.00% 0/18
Psychiatric disorders Nervousness	10.0% 2/20 • Number of events 2	10.5% 2/19 • Number of events 2	11.1% 2/18 • Number of events 2
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 1	36.8% 7/19 • Number of events 10	5.6% 1/18 • Number of events 1
General disorders Dizziness	10.0% 2/20 • Number of events 2	0.00% 0/19	0.00% 0/18

Additional Information

Dr. Jun Mao, Associate Professor

University of Pennsylvania

Phone: 215-746-2481

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place