Attention Deficit Hyperactivity DisorderPhase 2TREATNCT00279409
Treatment of Children With ADHD Who do Not Fully Respond to Stimulants
A Phase 2 study testing aripiprazole and Sugar pill in people with Attention Deficit Hyperactivity Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- aripiprazole and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Feb 2009
- Phase
- Phase 2
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- English or Spanish speaking parent/guardian. Parent/guardian and child must be able to understand the protocol.
- Primary diagnosis of ADHD despite treatment with a stimulant by the primary care treatment provider.
- Non-responder or partial responder to stimulant treatment. ADHD symptoms and clinical impairment despite treatment with stimulant (including OROS-MPH [Concerta] or mixed salts amphetamine [Adderall]).
- IQ of greater than 70.
- The subject must be in school.
- The family must be able to attend weekly visits.
Who cannot join
- Unable to understand protocol or follow study procedures.
- Subject doing well on stimulants.
- Subjects showing lack of response or minimal response to stimulants due to non-compliance with taking medication or taking suboptimal doses.
- Autism, Psychosis, Bipolar Disorder, Drug Abuse, significant suicidality, or any other psychiatric disorder (such as MDD, Anxiety Disorders, Eating Disorders) in addition to ADHD that will require treatment with additional medication or therapy.
- The subject is using or abusing recreational drugs or has a positive urine toxicology screen (except for stimulants).
- The subject has a history of physical, sexual, or emotional abuse that resulted in a clinically significant impact on clinical presentation, potentially driving some of the symptoms of ADHD.
Show all 10Show fewer
- Females who are pregnant or breast-feeding or who have a positive urine pregnancy test.
- Sexually active females and males who do not agree to use adequate birth control.
- Abnormal cardiac function.
- Subject is taking prohibited concomitant medication during phase 1 or phase 2 of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Developing More Efficacious Treatments for Children With ADHD Who Are "Partial" or "Non-responders" to Stimulants
The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.
Read the detailed description
We propose to do this with a single site, ten week, pilot study of 40 school age children, ages 6-17, with Attention-Deficit/ Hyperactivity Disorder (ADHD) and moderate or greater impairment (C-GAS < 55) who show ADHD symptoms despite a trial in the community with their primary care practitioner with either of two of the most commonly used stimulants (i.e., either OROS-MPH (Concerta) or mixed salts of amphetamine (Adderall-XR)).
These children first will be classified into three groups: Group 1, those who had been treated with a maximal dose of stimulant with partial or no response; Group 2, those treated with a suboptimal dose of stimulant and showing partial or no response, and Group 3, those who developed side effects that limited continued treatment with optimal doses of a stimulant.
The next step will be to enter these children into an open, two week trial to confirm their treatment resistance. Group 2, those treated with suboptimal doses, will have the dosage increased to the maximum recommended stimulant dose. Group 1, those who had been treated for 4 weeks with maximal doses of a stimulant, or Group 3, those who developed moderate to severe drug-related side effects, will be switched to the other class of stimulant for a two week trial, unless they have been tried on both classes. Those children will be maintained on their current class of stimulant for two weeks. At the end of the two weeks, all children will be rated on the ADHD-IV-RS by the Study Doctor. Those who have shown moderate to severe side effects or those who respond will exit the trial and be treated openly. Children from Group 2 who continue to show no improvement after a week will switch to the other stimulant. All children from Group 2 tried on both stimulants and all children from Groups 1 and 3 who continue to show mean scores greater than 1 SD over the mean for age will be referred to Phase 2.
During phase 2, they will be randomized to one of two treatment arms for eight weeks. The first treatment arm, the "simple treatment" arm, will consist of parent training plus continued treatment with a stimulant that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response, plus a placebo matching aripiprazole. The second treatment arm, called the "combination" arm, will consist of parent training plus continued treatment on stimulant plus augmentation with a second generation antipsychotic (aripiprazole). Aripiprazole (Abilify™ ) is a product that is FDA-approved and marketed for the treatment of schizophrenia and for the treatment of acute manic episodes associated with Bipolar I Disorder in adults only. However, aripiprazole is also used to treat children and adolescents with aggressive and oppositional disorders in standard clinical practice. We will continue randomizing patients until we have 40 children with ADHD become eligible to enter Phase 2.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- aripiprazole, Sugar pill
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Treatment resistant, Partial responder, Non-responder, Atypical Antipsychotic
- 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.
aripiprazoleDrug
Also called Abilify
double blind capsules (abilify or placebo) taken once daily, up to 10mg.
Sugar pillDrug
double blind capsules (abilify or placebo) taken once daily, up to 10mg.
| Study group | Role | What they receive |
|---|---|---|
| aripiprazole | Active comparator | This treatment arm (also called the "combination arm") consists of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus augmentation with aripiprazole. Aripiprazole pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis. Dosing will start at 2.5 mg and will be titrated up to 5 mg by week 1, and up to 10 mg by week 2 and for the remainder of the trial. Receives: Drug: aripiprazole |
| Sugar pill | Placebo comparator | This treatment arm (also called the "simple treatment" arm) will consist of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus a placebo matching aripiprazole. Placebo pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis. Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Rating Scale - IV (ADHD-RS-IV)
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startJul 2006
- Primary completionFeb 2008
- Study completionFeb 2009
Why it stopped: Recruitment Rate too slow
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.
- Other trials for Attention Deficit Hyperactivity 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Bristol-Myers Squibb, Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Laurence L Greenhill, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279409
- Sponsor's protocol ID
- 5064
- Other IDs
- P30MH071478
- Acronym
- TREAT
- Status last verified
- Jun 2020
- First submitted
- 18 Jan 2006
- Last updated
- 19 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing More Efficacious Treatments for Children With ADHD Who Are "Partial" or "Non-responders" to Stimulants
- ClinicalTrials.gov ID
- NCT00279409
- Acronym / sponsor ID
- TREAT / 5064
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, Treatment resistant, Partial responder, Non-responder, Atypical Antipsychotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment Rate too slow
- Enrolment
- 10 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Bristol-Myers Squibb, Otsuka Pharmaceutical Co., Ltd.
- Study start
- Jul 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 19 Jan 2006 (estimated)
- Results
- Posted 19 Jun 2020
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 pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.
Detailed description
We propose to do this with a single site, ten week, pilot study of 40 school age children, ages 6-17, with Attention-Deficit/ Hyperactivity Disorder (ADHD) and moderate or greater impairment (C-GAS < 55) who show ADHD symptoms despite a trial in the community with their primary care practitioner with either of two of the most commonly used stimulants (i.e., either OROS-MPH (Concerta) or mixed salts of amphetamine (Adderall-XR)).
These children first will be classified into three groups: Group 1, those who had been treated with a maximal dose of stimulant with partial or no response; Group 2, those treated with a suboptimal dose of stimulant and showing partial or no response, and Group 3, those who developed side effects that limited continued treatment with optimal doses of a stimulant.
The next step will be to enter these children into an open, two week trial to confirm their treatment resistance. Group 2, those treated with suboptimal doses, will have the dosage increased to the maximum recommended stimulant dose. Group 1, those who had been treated for 4 weeks with maximal doses of a stimulant, or Group 3, those who developed moderate to severe drug-related side effects, will be switched to the other class of stimulant for a two week trial, unless they have been tried on both classes. Those children will be maintained on their current class of stimulant for two weeks. At the end of the two weeks, all children will be rated on the ADHD-IV-RS by the Study Doctor. Those who have shown moderate to severe side effects or those who respond will exit the trial and be treated openly. Children from Group 2 who continue to show no improvement after a week will switch to the other stimulant. All children from Group 2 tried on both stimulants and all children from Groups 1 and 3 who continue to show mean scores greater than 1 SD over the mean for age will be referred to Phase 2.
During phase 2, they will be randomized to one of two treatment arms for eight weeks. The first treatment arm, the "simple treatment" arm, will consist of parent training plus continued treatment with a stimulant that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response, plus a placebo matching aripiprazole. The second treatment arm, called the "combination" arm, will consist of parent training plus continued treatment on stimulant plus augmentation with a second generation antipsychotic (aripiprazole). Aripiprazole (Abilify™ ) is a product that is FDA-approved and marketed for the treatment of schizophrenia and for the treatment of acute manic episodes associated with Bipolar I Disorder in adults only. However, aripiprazole is also used to treat children and adolescents with aggressive and oppositional disorders in standard clinical practice. We will continue randomizing patients until we have 40 children with ADHD become eligible to enter Phase 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aripiprazole | Active comparator | Drug: aripiprazoleThis treatment arm (also called the "combination arm") consists of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus augmentation with aripiprazole. Aripiprazole pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis. Dosing will start at 2.5 mg and will be titrated up to 5 mg by week 1, and up to 10 mg by week 2 and for the remainder of the trial. |
| Sugar pill | Placebo comparator | Drug: Sugar pillThis treatment arm (also called the "simple treatment" arm) will consist of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus a placebo matching aripiprazole. Placebo pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- English or Spanish speaking parent/guardian. Parent/guardian and child must be able to understand the protocol.
- Primary diagnosis of ADHD despite treatment with a stimulant by the primary care treatment provider.
- Non-responder or partial responder to stimulant treatment. ADHD symptoms and clinical impairment despite treatment with stimulant (including OROS-MPH [Concerta] or mixed salts amphetamine [Adderall]).
- IQ of greater than 70.
- The subject must be in school.
Key exclusion criteria (10 listed)
- Unable to understand protocol or follow study procedures.
- Subject doing well on stimulants.
- Subjects showing lack of response or minimal response to stimulants due to non-compliance with taking medication or taking suboptimal doses.
- Autism, Psychosis, Bipolar Disorder, Drug Abuse, significant suicidality, or any other psychiatric disorder (such as MDD, Anxiety Disorders, Eating Disorders) in addition to ADHD that will require treatment with additional medication or therapy.
- The subject is using or abusing recreational drugs or has a positive urine toxicology screen (except for stimulants).
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 |
|---|---|---|
| aripiprazoleAlso: Abilifydouble blind capsules (abilify or placebo) taken once daily, up to 10mg. | Drug | aripiprazole |
| Sugar pilldouble blind capsules (abilify or placebo) taken once daily, up to 10mg. | Drug | Sugar pill |
Primary outcome
ADHD Rating Scale - IV (ADHD-RS-IV)
Time frame: weekly
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Laurence L Greenhill, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aripiprazole and Sugar pill in people with Attention Deficit Hyperactivity Disorder, run by New York State Psychiatric Institute 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 19 Jun 2020. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Jun 2020). 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 Rating Scale - IV (ADHD-RS-IV) (time frame: weekly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2020.