NCT00429273

Brief Summary

This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6 years until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

4.5 years

First QC Date

January 29, 2007

Results QC Date

January 18, 2017

Last Update Submit

July 9, 2021

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHDGuanfacineMethylphenidateFocalin XRPediatricCognitive functionCombination therapy

Outcome Measures

Primary Outcomes (1)

  • ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale)

    The primary clinical efficacy variable for treatment was the ADHD-RS-IV (Attention-Deficit/Hyperactivity Disorder Rating Scale) Total Score and two sub-scales (Inattentive and Hyperactive-Impulsive ). The rating scale has 18 questions with answer options: None (0), Mild (1), Moderate (2) and Severe (3). Min 0; max 3. Scores are obtained by summing each item; The higher the score, the worse the outcome. Total score range: 0-54 Total Inattentive score range: 0-27 Total Hyperactive/Impulsive score range: 0-27

    Measured at baseline Week 4 and Week 8

Study Arms (3)

Group 1: Guan-Guan+Placebo

ACTIVE COMPARATOR

weeks 1-4: Guanfacine weeks 5-8: Guanfacine + Placebo

Drug: Guanfacine

Group 2: Placebo-Placebo+DMPH

ACTIVE COMPARATOR

weeks 1-4: Placebo weeks 5-8: Placebo+DMPH

Drug: Methylphenidate (MPH)

Group 3: Guan-Guan+DMPH (Comb)

EXPERIMENTAL

weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH

Drug: GuanfacineDrug: Methylphenidate (MPH)

Interventions

GuanfacineDRUG

Week 1: 0.5 mg twice daily; Week 2: 1 mg twice daily; Week 3: 1.5 mg twice daily; Weeks 4 through 8: best dose as determined by efficacy measures

Also known as: Tenex
Group 1: Guan-Guan+PlaceboGroup 3: Guan-Guan+DMPH (Comb)
Methylphenidate (MPH)DRUG

Participants less than 25 kg will receive 10 mg once daily for Week 5, 20 mg once daily for Week 6, and 30 mg once daily for Week 7. Subjects greater than 25 kg will receive 20 mg once daily for Week 5, 30 mg once daily for Week 6, 40 mg once daily for Week 7, and best doses as determined by efficacy measures for Week 8.

Also known as: Focalin XR
Group 2: Placebo-Placebo+DMPHGroup 3: Guan-Guan+DMPH (Comb)

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of DSM-IV ADHD by K-SADS-PL and confirmed by clinical interview
  • Clinical Global Impression-Severity score of at least 4 for ADHD
  • Resided with primary caretaker for at least 6 months prior to study entry

You may not qualify if:

  • History of autism, pervasive developmental disorder, chronic tic disorder, psychosis, or bipolar disorder
  • Current major depression or panic disorder
  • Systolic or diastolic blood pressure at screening greater than the 95th percentile or less than the 5th percentile for age and body mass index (BMI)
  • Any medical condition that might make stimulant or alpha agonist therapy medically inadvisable
  • Need for chronic use of other medications with central nervous system effects
  • Pregnant, breastfeeding, or beyond menarche and has a positive urine pregnancy test
  • History of structural heart defects, syncope, or fainting while exercising
  • Clinically significant cardiac abnormality as determined by echocardiogram (ECG) at study entry
  • Mental retardation as determined by clinical functional assessment and an IQ estimate of less than 70 based on Wechsler Adult Intelligence Scale (WAIS) subtests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (8)

  • Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.

    PMID: 41342306DERIVED

  • Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.

    PMID: 36971690DERIVED

  • Michelini G, Lenartowicz A, Vera JD, Bilder RM, McGough JJ, McCracken JT, Loo SK. Electrophysiological and Clinical Predictors of Methylphenidate, Guanfacine, and Combined Treatment Outcomes in Children With Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2023 Apr;62(4):415-426. doi: 10.1016/j.jaac.2022.08.001. Epub 2022 Aug 10.

    PMID: 35963559DERIVED

  • Michelini G, Lenartowicz A, Diaz-Fong JP, Bilder RM, McGough JJ, McCracken JT, Loo SK. Methylphenidate, Guanfacine, and Combined Treatment Effects on Electroencephalography Correlates of Spatial Working Memory in Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2023 Jan;62(1):37-47. doi: 10.1016/j.jaac.2022.06.017. Epub 2022 Aug 10.

    PMID: 35963558DERIVED

  • Sayer GR, McGough JJ, Levitt J, Cowen J, Sturm A, Castelo E, McCracken JT. Acute and Long-Term Cardiovascular Effects of Stimulant, Guanfacine, and Combination Therapy for Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2016 Dec;26(10):882-888. doi: 10.1089/cap.2015.0264. Epub 2016 Aug 2.

    PMID: 27483130DERIVED

  • Loo SK, Bilder RM, Cho AL, Sturm A, Cowen J, Walshaw P, Levitt J, Del'Homme M, Piacentini J, McGough JJ, McCracken JT. Effects of d-Methylphenidate, Guanfacine, and Their Combination on Electroencephalogram Resting State Spectral Power in Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2016 Aug;55(8):674-682.e1. doi: 10.1016/j.jaac.2016.04.020. Epub 2016 May 21.

    PMID: 27453081DERIVED

  • Bilder RM, Loo SK, McGough JJ, Whelan F, Hellemann G, Sugar C, Del'Homme M, Sturm A, Cowen J, Hanada G, McCracken JT. Cognitive Effects of Stimulant, Guanfacine, and Combined Treatment in Child and Adolescent Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2016 Aug;55(8):667-73. doi: 10.1016/j.jaac.2016.05.016. Epub 2016 Jun 7.

    PMID: 27453080DERIVED

  • McCracken JT, McGough JJ, Loo SK, Levitt J, Del'Homme M, Cowen J, Sturm A, Whelan F, Hellemann G, Sugar C, Bilder RM. Combined Stimulant and Guanfacine Administration in Attention-Deficit/Hyperactivity Disorder: A Controlled, Comparative Study. J Am Acad Child Adolesc Psychiatry. 2016 Aug;55(8):657-666.e1. doi: 10.1016/j.jaac.2016.05.015. Epub 2016 Jun 3.

    PMID: 27453079DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

GuanfacineMethylphenidateDexmethylphenidate Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Larger group sizes would enable more conclusive tests of treatment differences; Study design began with guanfacine first and addition of a stimulant second, making difficult to compare to those study designs adding guanfacine to ongoing stimulants.

Results Point of Contact

Title
James T. McCracken, M.D.
Organization
University of California, Los Angeles
jmccracken@mednet.ucla.edu
310-825-0470

Study Officials

  • James T. McCracken, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • James J. McGough, MD

    University of California, Los Angeles

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 31, 2007

Study Start

January 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 30, 2021

Results First Posted

June 14, 2017

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)