Clinical trial NCT01496248: Efficacy Study of Korean Red Ginseng to Treat Depression
Official title: The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
Residual symptoms
Korean red ginseng
Lead sponsor: Korea University
Sponsor class: OTHER
Collaborators: name: The Korean Society of Ginseng
First posted: 2011-12-21
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Depression Residual Symptom Scale
timeFrame: Baseline
measure: Depression Residual Symptom Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline
measure: Visual Analogue Scale
timeFrame: 8 weeks
measure: Montgomery Asberg Depression Rating Scale
timeFrame: Baseline
measure: Montgomery Asberg Depression Rating Scale
timeFrame: 8 weeks
measure: Clinical Global Index
timeFrame: Baseline
measure: Clinical Global Index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
Study officials:
affiliation: Korea University Medical Centre
name: Young-Hoon Ko, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeong HG, Ko YH, Oh SY, Han C, Kim T, Joe SH. Effect of Korean Red Ginseng as an adjuvant treatment for women with residual symptoms of major depression. Asia Pac Psychiatry. 2015 Sep;7(3):330-6. doi: 10.1111/appy.12169. Epub 2014 Dec 12.