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Efficacy Study of Korean Red Ginseng to Treat Depression

This study is currently recruiting participants.
Verified December 2011 by Korea University
Sponsor:
Collaborator:
The Korean Society of Ginseng
Information provided by (Responsible Party):
Young-Hoon Ko, Korea University
ClinicalTrials.gov Identifier:
NCT01496248
First received: December 18, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes

December 18, 2011
December 20, 2011
August 2011
May 2012   (final data collection date for primary outcome measure)
  • Depression Residual Symptom Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Depression Residual Symptom Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01496248 on ClinicalTrials.gov Archive Site
  • Visual analogue scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Visual analogue scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Mongtmery-Asberg Depression Rating Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Mongtmery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Clinical Global Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Korean Red Ginseng to Treat Depression
The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Dietary Supplement: 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.
Experimental: Korean Red Ginseng
Intervention: Dietary Supplement: Korean Red Ginseng
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
August 2012
May 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 55 Years
No
Contact: Tae-Hee Kim 82-31-412-5145 thkim3125@lycos.co.kr
Korea, Republic of
 
NCT01496248
R1105721
No
Young-Hoon Ko, Korea University
Korea University
The Korean Society of Ginseng
Not Provided
Korea University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP