Trial Outcomes & Findings for Efficacy Study of Korean Red Ginseng to Treat Depression (NCT NCT01496248)

Results Overview

This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Baseline

Results posted on

2014-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Korean Red Ginseng Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Overall Study STARTED	35
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of Korean Red Ginseng to Treat Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Korean Red Ginseng n=35 Participants Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Age, Continuous	45.1 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Korea, Republic of	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=25 Participants Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Depression Residual Symptom Scale	21.8 units on a scale Standard Deviation 12.7

PRIMARY outcome

Timeframe: 8 weeks

This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=25 Participants Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Depression Residual Symptom Scale	17.5 units on a scale Standard Deviation 11.1

SECONDARY outcome

Timeframe: Baseline

This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=25 Participants Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Visual Analogue Scale	31.4 units on a scale Standard Deviation 22.1

SECONDARY outcome

Timeframe: 8 weeks

This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=25 Participants Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Visual Analogue Scale	28.0 units on a scale Standard Deviation 26.5

SECONDARY outcome

Timeframe: Baseline

This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=25 Participants Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Montgomery Asberg Depression Rating Scale	6.7 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 8 weeks

This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=25 Participants Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Montgomery Asberg Depression Rating Scale	4.4 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline

This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=25 Participants Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Clinical Global Index	3.1 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 8 weeks

This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.

Outcome measures

Outcome measures
Measure	Korean Red Ginseng n=25 Participants Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Clinical Global Index	2.4 units on a scale Standard Deviation 0.5

Adverse Events

Korean Red Ginseng

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Korean Red Ginseng n=35 participants at risk Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Nervous system disorders headache	11.4% 4/35 • Number of events 4 • 8 weeks
Nervous system disorders sleep problem	14.3% 5/35 • Number of events 5 • 8 weeks

Additional Information

Young-Hoon Ko

Krea University College of Medicine

Phone: +82-31-412-5140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place