Major Depressive Disorder
Conditions
Keywords
Major depressive disorder, Residual symptoms, Korean red ginseng
Brief summary
The purpose of this study is to determine whether Korean Red Ginseng are effective in the treatment of the residual symptoms of depression as an adjuvant treatment.
Detailed description
Thirty-five female outpatients aging from 18 to 65 years, who were remitted from major depression with residual symptoms (Montgomery Asberg Depression Rating Scale, MADRS ≤ 12), were given Korean red ginseng at doses of 3g / day during 8 weeks.
Interventions
DIETARY_SUPPLEMENTKorean 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.
Sponsors
The Korean Society of Ginseng
Korea University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder. * Those who are in remission, which is defined as a MADRS score 8 on two consecutive visits at a 4-week interval. * Their primary psychiatric clinician determined that they would benefit from an adjuvant treatment of Korean red ginseng for residual symptoms.
Exclusion criteria
* Those who have a history of substance abuse or dependence within 1 month. * Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results. * Those who have a past history of hypersensitivity or intolerance to Korean red ginseng. * Those who participated in clinical trials within 1 month before entering the study entry. * Those who are pregnant or are breast feeding. * Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study. * The patients unable/unlikely to comprehend/follow the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Residual Symptom Scale | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 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). |
| Montgomery Asberg Depression Rating Scale | 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. |
| Clinical Global Index | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Korean Red Ginseng |
|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment Korea, Republic of | 35 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Depression Residual Symptom Scale
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Depression Residual Symptom Scale | 21.8 units on a scale | Standard Deviation 12.7 |
p-value: <0.05ANOVA
Primary
Depression Residual Symptom Scale
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).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Depression Residual Symptom Scale | 17.5 units on a scale | Standard Deviation 11.1 |
p-value: <0.05ANOVA
Secondary
Clinical Global Index
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Clinical Global Index | 2.4 units on a scale | Standard Deviation 0.5 |
p-value: <0.05ANOVA
Secondary
Clinical Global Index
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Clinical Global Index | 3.1 units on a scale | Standard Deviation 0.5 |
p-value: <0.05ANOVA
Secondary
Montgomery Asberg Depression Rating Scale
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Montgomery Asberg Depression Rating Scale | 6.7 units on a scale | Standard Deviation 2.7 |
p-value: <0.05ANOVA
Secondary
Montgomery Asberg Depression Rating Scale
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Montgomery Asberg Depression Rating Scale | 4.4 units on a scale | Standard Deviation 3.1 |
p-value: <0.05ANOVA
Secondary
Visual Analogue Scale
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Visual Analogue Scale | 31.4 units on a scale | Standard Deviation 22.1 |
p-value: <0.05ANOVA
Secondary
Visual Analogue Scale
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).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Korean Red Ginseng | Visual Analogue Scale | 28.0 units on a scale | Standard Deviation 26.5 |
p-value: <0.05ANOVA