Efficacy Study of Korean Red Ginseng to Treat Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Korea University.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Dietary Supplement: Korean Red Ginseng

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Korean Red Ginseng 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496248

Contacts
Contact: Tae-Hee Kim 82-31-412-5145 thkim3125@lycos.co.kr

Locations
Korea, Republic of
Korea University Ansan Hospital Recruiting
Ansan, Gyeonggi-do, Korea, Republic of, 425-707
Contact: Tae-Hee Kim    +82-31-412-5145    thkim3125@lycos.co.kr   
Principal Investigator: Young-Hoon Ko, M.D.         
Sponsors and Collaborators
Korea University
The Korean Society of Ginseng
  More Information

No publications provided

Responsible Party: Young-Hoon Ko, Associate Professor, Korea University
ClinicalTrials.gov Identifier: NCT01496248     History of Changes
Other Study ID Numbers: R1105721
Study First Received: December 18, 2011
Last Updated: December 20, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University:
Major depressive disorder
Residual symptoms
Korean red ginseng

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014