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

NCT00279409 | Terminated Phase 2 Results DMC

• 2 other identifiers: 5064P30MH071478
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; ADHD; Treatment resistant; Partial responder; Non-responder; Atypical Antipsychotic

Outcome Measures

Primary Outcomes (1)

• ADHD Rating Scale - IV (ADHD-RS-IV)

  weekly

Study Arms (2)

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.

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.

Drug: Sugar pill

Interventions

aripiprazole DRUG

double blind capsules (abilify or placebo) taken once daily, up to 10mg.

Also known as: Abilify

aripiprazole

Sugar pill DRUG

double blind capsules (abilify or placebo) taken once daily, up to 10mg.

Sugar pill

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator
• Bristol-Myers Squibb: collaborator
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Aripiprazole; Sugars

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Results Point of Contact

• Title: Laurence Greenhill
• Organization: USSF

larrylgreenhill@gmail.com

Study Officials

• Laurence L Greenhill, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2006
• First Posted: January 19, 2006
• Study Start: July 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2009
• Last Updated: June 19, 2020
• Results First Posted: June 19, 2020

Record last verified: 2020-06

Locations

US (1)