The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Korea University
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Depression Residual Symptom Scale
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts 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.
Outcomes
Primary Outcomes
Depression Residual Symptom Scale
Time Frame: 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 Outcomes
- Visual Analogue Scale(8 weeks)
- Montgomery Asberg Depression Rating Scale(8 weeks)
- Clinical Global Index(8 weeks)
Investigators
Young-Hoon Ko
Associate Professor
Korea University