Efficacy Study of Korean Red Ginseng to Treat Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Korean Red Ginseng

Extract of Korean red ginseng was administrated to subjects through capsule form.

Group Type EXPERIMENTAL

Korean Red Ginseng

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No