Efficacy Study of Korean Red Ginseng to Treat Depression

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Korean Red Ginseng	Korean Red Ginseng	Extract of Korean red ginseng was administrated to subjects through capsule form.

Primary Outcome Measures

Name	Time	Method
Depression Residual Symptom Scale	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).

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale	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).
Montgomery Asberg Depression Rating Scale	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.
Clinical Global Index	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.