Mental DisordersPhase 3ADHDNCT01536210
Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract in Children With ADHD(Attention Deficit Hyperactivity Disorder)
A Phase 3 study testing YY-162 in people with Mental Disorders, run by Yuyu Pharma, Inc. at 3 sites in South Korea.
Trial summary
This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- YY-162
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Dec 2011to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mele and female subjects aged from 6 to 15
- Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K)interview
- Subjects signed a written consent form voluntarily
- Patient's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates or legal guardian.
- Subjects who can keep visit schedule and whose parent/parent surrogates or legal guardian can willingly complete assessments defined in the study protocol.
- Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time.
Who cannot join
- Subjects who have difficulty swallowing tablet.
- Subjects who have known allergy to plant extracts.
- Subjects who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy.
- Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder.
- Subjects who have significant suicidal ideation.
- Subjects with mental retardation.
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- Subjects with Tourette's syndrome requiring drug therapy.
- Subjects who have been administrated Methylphenidate or Atomoxetine within recent 3 months and Ginkgo extract or Ginseng extract within recent 1 month.
- Subjects who currently have a significant medical conditions(e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma)
- Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results including serum chemistries and hematology.
- subjects who are currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant.
- subjects who receive psychosocial treatment during the drug trial.
- Subjects who are not able to swallow the study drug.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Hallym University Hospital
Anyang-si, 431-070
Inje University Ilsan Paik Hospital
Goyang-si, 411-706
Seoul National University Hospital
Seoul, 110-744
About this study
Official title: Randomized, Double-Blind, Placebo-control, Multicenter Study, the Efficacy and Safety of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD(Attention Deficit Hyperactivity Disorder)in 8 Weeks
This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD.
Read the detailed description
This is Double-Blind, two arms, multi-center, Interventional, 8 weeks study starting with YY-162(Combination of Ginkgo extract and Ginseng extract)in children with ADHD. Assessment of efficacy and safety will be performed at the baseline, weeks 2, 4 and 8. At the first visit, a full psychiatric history, demographic date and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will performed; K-ARS, IOWA conner's rating scale, CGI-S/I, ATA, Children's color trails test and stroop test, intelligence test(from KEDI-WISC)and adverse event reporting.
- Conditions
- Mental Disorders
- Being tested
- YY-162, Placebo
- Keywords
- ADHD(attention Deficit Hyperactivity Disorder)
- Medical subject headings
- Mental Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YY-162Drug
Also called combination of Ginkgo extract and Ginseng extract
YY-162(Ginkgo extract 30mg + Ginseng extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication
PlaceboDrug
Placebo 1T/ Three times a day (tid) for 8 weeks, PO medication
| Study group | Role | What they receive |
|---|---|---|
| YY-162 | Experimental | YY-162(Ginkgo Extract 30mg + Ginseng Extract 50mg)
1T/Three times a day(Tid) for 8 weeks, PO medication Receives: Drug: YY-162 |
| Placebo | Placebo comparator | Placebo 1T /Three times a day(Tid) for 8 weeks, PO medication Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Korea-ADHD Rating scale
Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by patents at baseline, after 8 weeks.
Measured: within the first 8 weeks (plus or minus 5 days) after adminitration
Secondary outcomes (5)
IOWA conner's rating scale
Validated questionnaire about core ADHD symptoms(IOWA Conner's rating scale) filled out by parents at baseline, after 2,4 weeks and closeout
Measured: baseline, after 2, 4, and 8 weeks
Clinical Global Impression(Severity and Improvement)
Clinical Global Impression(Severity and Improvement)rated by treating physician at baseline, after2,4 weeks and closeout
Measured: baseline, after 2, 4, and 8 weeks
Advanced Test of Attention
Advanced Test of Attention and baseline and closeout Attention Diagnostic system(visual and auditory) at baseline and closeout
Measured: baseline and 8 weeks
children's color trails test and stroop test
Children's color trails test and stroop test at baseline and closeout
Measured: baseline and 8 weeks
Intelligence test(from KEDI-WISC)
Intelligence test(from KEDI-WISC)at screening and closeout
Measured: screening and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuyu Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SooChurl Cho, MD, PhD, Principal investigator, Seoul National University HospitalHyunJu Hong, MD, PhD, Principal investigator, Hallym University HospitalEunJin Park, MD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536210
- Sponsor's protocol ID
- YY-162 (b)
- Acronym
- ADHD
- Status last verified
- Feb 2019
- First submitted
- 9 Jan 2012
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lyon MR, Cline JC, Totosy de Zepetnek J, Shan JJ, Pang P, Benishin C. Effect of the herbal extract combination Panax quinquefolium and Ginkgo biloba on attention-deficit hyperactivity disorder: a pilot study. J Psychiatry Neurosci. 2001 May;26(3):221-8.
PubMed 11394191
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-control, Multicenter Study, the Efficacy and Safety of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD(Attention Deficit Hyperactivity Disorder)in 8 Weeks
- ClinicalTrials.gov ID
- NCT01536210
- Acronym / sponsor ID
- ADHD / YY-162 (b)
- Conditions
- Mental Disorders
- Keywords
- ADHD(attention Deficit Hyperactivity Disorder)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Yuyu Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD.
Detailed description
This is Double-Blind, two arms, multi-center, Interventional, 8 weeks study starting with YY-162(Combination of Ginkgo extract and Ginseng extract)in children with ADHD. Assessment of efficacy and safety will be performed at the baseline, weeks 2, 4 and 8. At the first visit, a full psychiatric history, demographic date and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will performed; K-ARS, IOWA conner's rating scale, CGI-S/I, ATA, Children's color trails test and stroop test, intelligence test(from KEDI-WISC)and adverse event reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YY-162 | Experimental | Drug: YY-162YY-162(Ginkgo Extract 30mg + Ginseng Extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 1T /Three times a day(Tid) for 8 weeks, PO medication |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Mele and female subjects aged from 6 to 15
- Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K)interview
- Subjects signed a written consent form voluntarily
- Patient's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates or legal guardian.
- Subjects who can keep visit schedule and whose parent/parent surrogates or legal guardian can willingly complete assessments defined in the study protocol.
Key exclusion criteria (13 listed)
- Subjects who have difficulty swallowing tablet.
- Subjects who have known allergy to plant extracts.
- Subjects who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy.
- Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder.
- Subjects who have significant suicidal ideation.
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 |
|---|---|---|
| YY-162Also: combination of Ginkgo extract and Ginseng extractYY-162(Ginkgo extract 30mg + Ginseng extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication | Drug | YY-162 |
| PlaceboPlacebo 1T/ Three times a day (tid) for 8 weeks, PO medication | Drug | Placebo |
Primary outcome
Korea-ADHD Rating scale
Time frame: within the first 8 weeks (plus or minus 5 days) after adminitration
Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by patents at baseline, after 8 weeks.
5 secondary outcomes
IOWA conner's rating scale
Time frame: baseline, after 2, 4, and 8 weeks
Clinical Global Impression(Severity and Improvement)
Time frame: baseline, after 2, 4, and 8 weeks
Advanced Test of Attention
Time frame: baseline and 8 weeks
children's color trails test and stroop test
Time frame: baseline and 8 weeks
Intelligence test(from KEDI-WISC)
Time frame: screening and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Results publication: PubMed 11394191Lyon MR, Cline JC, Totosy de Zepetnek J, Shan JJ, Pang P, Benishin C. Effect of the herbal extract combination Panax quinquefolium and Ginkgo biloba on attention-deficit hyperactivity disorder: a pilot study. J Psychiatry Neurosci. 2001 May;26(3):221-8.
- Effect of the herbal extract combination Panax quinquifolius and Ginkgo biloba on attention-deficit hyperactivity disorder: a pilot studyLink provided by the sponsor.
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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.
SooChurl Cho, MD, PhD principal investigator
Seoul National University Hospital
HyunJu Hong, MD, PhD principal investigator
Hallym University Hospital
EunJin Park, MD principal investigator
Inje University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YY-162 in people with Mental Disorders, run by Yuyu Pharma, Inc. at 3 sites 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 6 inclusion and 13 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Korea-ADHD Rating scale (time frame: within the first 8 weeks (plus or minus 5 days) after adminitration). 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 NCT01536210, 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 25 Feb 2019.