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Treatment of Children With ADHD Who do Not Fully Respond to Stimulants (TREAT)

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ClinicalTrials.gov Identifier: NCT00279409
Recruitment Status : Terminated (Recruitment Rate too slow)
First Posted : January 19, 2006
Results First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Bristol-Myers Squibb
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: aripiprazole Drug: Sugar pill Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing More Efficacious Treatments for Children With ADHD Who Are "Partial" or "Non-responders" to Stimulants
Study Start Date : July 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: aripiprazole
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.
Drug: aripiprazole
double blind capsules (abilify or placebo) taken once daily, up to 10mg.
Other Name: Abilify

Placebo Comparator: Sugar pill
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.
Drug: Sugar pill
double blind capsules (abilify or placebo) taken once daily, up to 10mg.




Primary Outcome Measures :
  1. ADHD Rating Scale - IV (ADHD-RS-IV) [ Time Frame: weekly ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. English or Spanish speaking parent/guardian. Parent/guardian and child must be able to understand the protocol.
  2. Primary diagnosis of ADHD despite treatment with a stimulant by the primary care treatment provider.
  3. 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]).
  4. IQ of greater than 70.
  5. The subject must be in school.
  6. The family must be able to attend weekly visits.

Exclusion Criteria:

  1. Unable to understand protocol or follow study procedures.
  2. Subject doing well on stimulants.
  3. Subjects showing lack of response or minimal response to stimulants due to non-compliance with taking medication or taking suboptimal doses.
  4. 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.
  5. The subject is using or abusing recreational drugs or has a positive urine toxicology screen (except for stimulants).
  6. 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.
  7. Females who are pregnant or breast-feeding or who have a positive urine pregnancy test.
  8. Sexually active females and males who do not agree to use adequate birth control.
  9. Abnormal cardiac function.
  10. Subject is taking prohibited concomitant medication during phase 1 or phase 2 of the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279409


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Bristol-Myers Squibb
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Laurence L Greenhill, MD New York State Psychiatric Institute
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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00279409    
Other Study ID Numbers: 5064
P30MH071478 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2006    Key Record Dates
Results First Posted: June 19, 2020
Last Update Posted: June 19, 2020
Last Verified: June 2020
Keywords provided by New York State Psychiatric Institute:
Attention Deficit Hyperactivity Disorder
ADHD
Treatment resistant
Partial responder
Non-responder
Atypical Antipsychotic
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists