Major Depressive DisorderNCT01496248
Efficacy Study of Korean Red Ginseng to Treat Depression
A study testing Korean Red Ginseng in people with Major Depressive Disorder, run by Korea University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Korean Red Ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 425-707
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Korean Red Ginseng
- Keywords
- Major depressive disorder, Residual symptoms, Korean red ginseng
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean Red GinsengDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Korean Red Ginseng | Experimental | Extract of Korean red ginseng was administrated to subjects through capsule form. Receives: Dietary Supplement: Korean Red Ginseng |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Residual Symptom Scale
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).
Measured: Baseline
Depression Residual Symptom Scale
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).
Measured: 8 weeks
Secondary outcomes (6)
Visual Analogue Scale
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).
Measured: Baseline
Visual Analogue Scale
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).
Measured: 8 weeks
Montgomery Asberg Depression Rating Scale
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.
Measured: Baseline
Montgomery Asberg Depression Rating Scale
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.
Measured: 8 weeks
Clinical Global Index
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.
Measured: Baseline
Clinical Global Index
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Society of Ginseng
- Responsible party
- Principal investigator, Young-Hoon Ko, Korea University
- Investigators
- Young-Hoon Ko, M.D., Ph.D., Principal investigator, Korea University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496248
- Sponsor's protocol ID
- R1105721
- Status last verified
- Oct 2014
- First submitted
- 18 Dec 2011
- Last updated
- 10 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 25504813
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Korean Red Ginseng as Adjuvant Treatment for the Residual Symptoms of Depression
- ClinicalTrials.gov ID
- NCT01496248
- Acronym / sponsor ID
- R1105721
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, Residual symptoms, Korean red ginseng
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Collaborators
- The Korean Society of Ginseng
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Posted 10 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Korean Red Ginseng | Experimental | Dietary Supplement: Korean Red GinsengExtract of Korean red ginseng was administrated to subjects through capsule form. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Korean Red Ginseng100% 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. | Dietary supplement | Korean Red Ginseng |
Primary outcome
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).
6 secondary outcomes
Visual Analogue Scale
Time frame: Baseline
Visual Analogue Scale
Time frame: 8 weeks
Montgomery Asberg Depression Rating Scale
Time frame: Baseline
Montgomery Asberg Depression Rating Scale
Time frame: 8 weeks
Clinical Global Index
Time frame: Baseline
Clinical Global Index
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25504813Jeong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Hoon Ko, M.D., Ph.D. principal investigator
Korea University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Korean Red Ginseng in people with Major Depressive Disorder, run by Korea University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Residual Symptom Scale (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01496248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2014.