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Efficacy Study of Korean Red Ginseng to Treat Depression

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ClinicalTrials.gov Identifier: NCT01496248
Recruitment Status : Completed
First Posted : December 21, 2011
Results First Posted : October 10, 2014
Last Update Posted : October 10, 2014
Sponsor:
Collaborator:
The Korean Society of Ginseng
Information provided by (Responsible Party):
Young-Hoon Ko, Korea University

Tracking Information
First Submitted Date  ICMJE December 18, 2011
First Posted Date  ICMJE December 21, 2011
Results First Submitted Date  ICMJE September 24, 2014
Results First Posted Date  ICMJE October 10, 2014
Last Update Posted Date October 10, 2014
Study Start Date  ICMJE August 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
  • Depression Residual Symptom Scale [ Time Frame: Baseline ]
    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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2011)
  • Depression Residual Symptom Scale [ Time Frame: Baseline ]
  • Depression Residual Symptom Scale [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT01496248 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
  • Visual Analogue Scale [ Time Frame: Baseline ]
    This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).
  • Visual Analogue Scale [ Time Frame: 8 weeks ]
    This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).
  • Montgomery Asberg Depression Rating Scale [ Time Frame: Baseline ]
    This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.
  • Montgomery Asberg Depression Rating Scale [ Time Frame: 8 weeks ]
    This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.
  • Clinical Global Index [ Time Frame: Baseline ]
    This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.
  • Clinical Global Index [ Time Frame: 8 weeks ]
    This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2011)
  • Visual Analogue Scale [ Time Frame: Baseline ]
  • Visual Analogue Scale [ Time Frame: 8 weeks ]
  • Mongtmery-Asberg Depression Rating Scale [ Time Frame: Baseline ]
  • Mongtmery-Asberg Depression Rating Scale [ Time Frame: 8 weeks ]
  • Clinical Global Index [ Time Frame: Baseline ]
  • Clinical Global Index [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Korean Red Ginseng to Treat Depression
Official Title  ICMJE The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Korean Red Ginseng
Extract of Korean red ginseng was administrated to subjects through capsule form.
Intervention: Dietary Supplement: Korean Red Ginseng
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2014)
35
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2011)
40
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01496248
Other Study ID Numbers  ICMJE R1105721
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Young-Hoon Ko, Korea University
Study Sponsor  ICMJE Korea University
Collaborators  ICMJE The Korean Society of Ginseng
Investigators  ICMJE
Principal Investigator: Young-Hoon Ko, M.D., Ph.D. Korea University Medical Centre
PRS Account Korea University
Verification Date October 2014

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