Attention Deficit Disorder With HyperactivityPhase 4Project1NCT00429273
Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
A Phase 4 study testing Guanfacine and Methylphenidate (MPH) in people with Attention Deficit Disorder With Hyperactivity, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Guanfacine and Methylphenidate (MPH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2011
- Phase
- Phase 4
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: An Eight-Week, Randomized, Double-Blind Comparison of Guanfacine, Focalin XR, and the Combination, With a Twelve Month Open-Label Extension for the Treatment of ADHD in Pediatric Subjects Aged 7 to 14 Years
This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
Read the detailed description
Attention deficit hyperactivity disorder (ADHD) is one of the most common childhood mental disorders. Children with ADHD have impaired functioning in multiple settings, including home and school. They also have difficulty relating with peers. If left untreated, the disorder may cause adverse effects that can last into adolescence and adulthood. Stimulant medications, such as methylphenidate, are effective in reducing ADHD symptoms on a short-term basis. However, few long-term benefits in academic or general functioning from current ADHD therapies have been demonstrated. Focalin XR is a stimulant medication that is FDA-approved for treating ADHD. Guanfacine is another medication that is currently approved for the treatment of hypertension, but has long been used for treating ADHD. This study will determine the effectiveness of a combination of Focalin XR and guanfacine in enhancing cognitive functioning and improving the long-term benefit of ADHD treatment.
Participants in this study will be randomly assigned to one of three treatment regimens: Methylphenidate (Focalin XR) and placebo; guanfacine and placebo; or Focalin XR and guanfacine. The study will be conducted in two phases: an 8-week double-blind treatment phase and a 12-month open-label treatment phase. In Phase I, one third of participants will receive placebo for the initial 4 weeks, followed by Focalin XR alone for the remaining 4 weeks. All other participants will receive their assigned medications for the full 8 weeks. All participants will attend two study visits prior to beginning treatment and one study visit per week throughout Phase I. At the end of Phase I, treatment assignments will be unblinded. Participants who experienced adequate improvement with their assigned treatment will then continue in Phase II on the same medication(s) for an additional 12 months. Participants will attend study visits once per month until the end of the study. Study visits will include self-report measures, clinical assessments, and cognitive testing. Participants will also undergo four electroencephalography (EEG) tests and two fMRI scans over the course of the study. All Phase II participants will receive a follow-up telephone call 1 month after the final study visit.
- Being tested
- Guanfacine, Methylphenidate (MPH)
- Keywords
- ADHD, Guanfacine, Methylphenidate, Focalin XR, Pediatric, Cognitive function, Combination therapy
- 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.
GuanfacineDrug
Also called Tenex
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
Methylphenidate (MPH)Drug
Also called Focalin XR
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Guan-Guan+Placebo | Active comparator | weeks 1-4: Guanfacine weeks 5-8: Guanfacine + Placebo Receives: Drug: Guanfacine |
| Group 2: Placebo-Placebo+DMPH | Active comparator | weeks 1-4: Placebo weeks 5-8: Placebo+DMPH Receives: Drug: Methylphenidate (MPH) |
| Group 3: Guan-Guan+DMPH (Comb) | Experimental | weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH Receives: Drug: Guanfacine; Drug: Methylphenidate (MPH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2011
- Study completionJul 2011
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 (8)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, James McCracken, University of California, Los Angeles
- Investigators
- James T. McCracken, MD, Principal investigator, University of California, Los AngelesJames J. McGough, MD, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429273
- Sponsor's protocol ID
- P50MH077248-01
- Other IDs
- P50MH077248-01, 10-000453
- Acronym
- Project1
- Status last verified
- Jul 2021
- First submitted
- 29 Jan 2007
- Last updated
- 30 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41342306Storebo 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.
PubMed 36971690Michelini 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.
PubMed 35963559Michelini 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.
PubMed 35963558Sayer 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.
PubMed 27483130Loo 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.
PubMed 27453081Bilder 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.
PubMed 27453080McCracken 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.
PubMed 27453079
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-Week, Randomized, Double-Blind Comparison of Guanfacine, Focalin XR, and the Combination, With a Twelve Month Open-Label Extension for the Treatment of ADHD in Pediatric Subjects Aged 7 to 14 Years
- ClinicalTrials.gov ID
- NCT00429273
- Acronym / sponsor ID
- Project1 / P50MH077248-01
- Keywords
- ADHD, Guanfacine, Methylphenidate, Focalin XR, Pediatric, Cognitive function, Combination therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 31 Jan 2007 (estimated)
- Results
- Posted 14 Jun 2017
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 the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
Detailed description
Attention deficit hyperactivity disorder (ADHD) is one of the most common childhood mental disorders. Children with ADHD have impaired functioning in multiple settings, including home and school. They also have difficulty relating with peers. If left untreated, the disorder may cause adverse effects that can last into adolescence and adulthood. Stimulant medications, such as methylphenidate, are effective in reducing ADHD symptoms on a short-term basis. However, few long-term benefits in academic or general functioning from current ADHD therapies have been demonstrated. Focalin XR is a stimulant medication that is FDA-approved for treating ADHD. Guanfacine is another medication that is currently approved for the treatment of hypertension, but has long been used for treating ADHD. This study will determine the effectiveness of a combination of Focalin XR and guanfacine in enhancing cognitive functioning and improving the long-term benefit of ADHD treatment.
Participants in this study will be randomly assigned to one of three treatment regimens: Methylphenidate (Focalin XR) and placebo; guanfacine and placebo; or Focalin XR and guanfacine. The study will be conducted in two phases: an 8-week double-blind treatment phase and a 12-month open-label treatment phase. In Phase I, one third of participants will receive placebo for the initial 4 weeks, followed by Focalin XR alone for the remaining 4 weeks. All other participants will receive their assigned medications for the full 8 weeks. All participants will attend two study visits prior to beginning treatment and one study visit per week throughout Phase I. At the end of Phase I, treatment assignments will be unblinded. Participants who experienced adequate improvement with their assigned treatment will then continue in Phase II on the same medication(s) for an additional 12 months. Participants will attend study visits once per month until the end of the study. Study visits will include self-report measures, clinical assessments, and cognitive testing. Participants will also undergo four electroencephalography (EEG) tests and two fMRI scans over the course of the study. All Phase II participants will receive a follow-up telephone call 1 month after the final study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Guan-Guan+Placebo | Active comparator | Drug: Guanfacineweeks 1-4: Guanfacine weeks 5-8: Guanfacine + Placebo |
| Group 2: Placebo-Placebo+DMPH | Active comparator | Drug: Methylphenidate (MPH)weeks 1-4: Placebo weeks 5-8: Placebo+DMPH |
| Group 3: Guan-Guan+DMPH (Comb) | Experimental | Drug: Guanfacine, Drug: Methylphenidate (MPH)weeks 1-4: Guanfacine weeks 5-8: Guanfacine+DMPH |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| GuanfacineAlso: TenexWeek 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 | Drug | Group 1: Guan-Guan+Placebo, Group 3: Guan-Guan+DMPH (Comb) |
| Methylphenidate (MPH)Also: Focalin XRParticipants 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. | Drug | Group 2: Placebo-Placebo+DMPH, Group 3: Guan-Guan+DMPH (Comb) |
Primary outcome
ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale)
Time frame: Measured at baseline Week 4 and Week 8
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41342306Storebo 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.
- Derived from this study: PubMed 36971690Storebo 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.
- Derived from this study: PubMed 35963559Michelini 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.
- Derived from this study: PubMed 35963558Michelini 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.
- Derived from this study: PubMed 27483130Sayer 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.
- Derived from this study: PubMed 27453081Loo 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.
- Derived from this study: PubMed 27453080Bilder 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.
- Derived from this study: PubMed 27453079McCracken 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.
- Individual participant dataSharing planned: No
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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.
James T. McCracken, MD principal investigator
University of California, Los Angeles
James J. McGough, MD study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guanfacine and Methylphenidate (MPH) in people with Attention Deficit Disorder With Hyperactivity, run by University of California, Los Angeles at 1 site in United States.
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 9 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 30 Jul 2021. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). 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?
ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale) (time frame: Measured at baseline Week 4 and Week 8). 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 NCT00429273, which also lists 8 linked publications.
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 30 Jul 2021.