Efficacy Study of Korean Red Ginseng to Treat Depression

Study Overview
=================
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.

Official Title
-----------------
The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: Korean Red Ginseng


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Korean Red Ginseng<br>Extract of Korean red ginseng was administrated to subjects through capsule form. | Dietary Supplement: Korean Red Ginseng<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline | 
| 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). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline | 
| 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). | 8 weeks | 
| 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. | Baseline | 
| 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. | 8 weeks | 
| 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. | Baseline | 
| 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. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major depressive disorder, Residual symptoms, Korean red ginseng