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Attention Deficit Hyperactivity DisorderNCT02482649

EAA/Therapy for Treating Children With ADHD

A study testing EAA/T, Methylphenidate and Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is 1) to investigate clinical effects of equine-assisted activities and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD) and 2) to compare the clinical effect of EAA/T and drug therapy in children 6-13-years-of-age. Read more about this study

Who is it for?
Ages 6 to 13 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
EAA/T, Methylphenidate and Atomoxetine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteSouth Korea
Study dates
Jan 2013to Dec 2015
Phase
Interventional
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 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • a diagnosis of ADHD according to Diagnostic and Statistical Manual-IV-Text Version(DSM-IV-TR) and Korean Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Life¬time Version (K-SADS-PL)

Who cannot join

  • (1) a learning disorder or an intelligence quotient (IQ) measured by the Korean Wechsler Intelligence Scale for Children-IV (K-WISC-IV) < 70, (2) significant medical condition, schizophrenia or other psychotic disorder, bipolar disorder, a history of alcohol or drug dependence, neurologic disorders, epilepsy, and organic mental disorders; (3) a major depressive disorder that required pharmacotherapy; (4) significant suicidal ideation; (5) a Tourette's disorder or obsessive-compulsive disorder that required pharmacotherapy; (6) use of methylphenidate or atomoxetine within 90 days of baseline

Trial locations and contacts

1 site in 1 country.

Yoo-Sook Joung, M.D.,Ph.D. contact

82-2-3410-0930

yschoung@skku.edu

South Korea1 site, 1 recruiting

  • Yoo-Sook Joung

    Seoul, 135-710

    Yoo-Sook Joung, M.D., Ph.D., 82-2-3410-0930, yschoung@skku.edu

    Recruiting

Other trials in South Korea

About this study

Official title: Equine-Assisted Activities and Therapy for Treating Children With Attention-Deficit/Hyperactivity Disorder

The aim of this study is 1) to investigate clinical effects of equine-assisted activities and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD) and 2) to compare the clinical effect of EAA/T and drug therapy in children 6-13-years-of-age. This study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of EAA/T. Forty six subjects will be enrolled and various clinical tests will be administered at baseline and after EAA/T or drug therapy.

Read the detailed description

This study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of EAA/T. Forty six subjects will be aasigned 12 weeks of EAA/T or drug therapy, and various clinical tests will be administered at baseline and after EAA/T or drug therapy. Assessments included the investigator-administered ADHD-Rating Scale (ARS-I), Clinical Global Impressions - Severity scale (CGI-S), Clinical Global Impressions - Improvement scale (CGI-I), Gordon Diagnostic System (GDS), Korea-Child Behavior Checklist (K-CBCL), Self-Esteem Scale (SES), Bruininks-Oseretsky test of motor proficiency, second edition (BOT-2), and quantitative electroencephalography (QEEG) or functional magnetic resonance imaging(fMRI) study. This study has two objectives. The first objective is to investigate clinical effects of equine-assisted activities and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD). For this one, we determine the treatment response rate as the primary outcome measure. The treatment response is defined as ≥ 30% decline than baseline in the ARS-I score or in CGI-I scores of 1 or 2 to endpoint. The second objective is to compare the clinical effect of EAA/T and drug therapy in children with ADHD.

Being tested
EAA/T, Methylphenidate, Atomoxetine
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EAA/TBehavioural

    Also called Equine-Assisted Activities and Therapy, Hyppotherapy

    bi-weekly for 12weeks

  • MethylphenidateDrug

    Also called Cencerta, Metadate

    dosage adjustment according to clinical effectiveness, QD for 12weeks

  • AtomoxetineDrug

    Also called Strattera

    dosage adjustment according to clinical effectiveness, QD or BID, for 12weeks

Study groups in NCT02482649
Study groupRoleWhat they receive
EAA/TExperimentalEAA/TEquine-Assisted Activities and Therapy) bi-weekly for 12eeks
Receives: Behavioral: EAA/T
DrugsActive comparatorMethylphenidate or Atomoxetine
Receives: Drug: Methylphenidate; Drug: Atomoxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. chane of ARS-I score

    change of Investigator-administered ADHD-Rating Scale (ARS-I) after Equine-Assisted Therapy

    Measured: change measures (baseline and 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2015 (estimated)
  2. Study startJan 2013
  3. Primary completionAug 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02482649
Sponsor's protocol ID
2012-12-049
Status last verified
Jun 2015
First submitted
24 Jun 2015
Last updated
26 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing EAA/T, Methylphenidate and Atomoxetine in people with Attention Deficit Hyperactivity Disorder, run by Samsung Medical Center 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 2015. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yoo-Sook Joung, M.D.,Ph.D. (82-2-3410-0930, yschoung@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

chane of ARS-I score (time frame: change measures (baseline and 12 weeks)). 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 NCT02482649.

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 26 Jun 2015.

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