Trial Outcomes & Findings for Treatment of Children With ADHD Who do Not Fully Respond to Stimulants (NCT NCT00279409)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

weekly

Results posted on

2020-06-19

Participant milestones
Measure	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. aripiprazole: double blind capsules (abilify or placebo) taken once daily, up to 10mg.	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. Sugar pill: double blind capsules (abilify or placebo) taken once daily, up to 10mg.
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

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

Baseline data not reported

Timeframe: weekly

Population: Despite all efforts to contact the study team members to obtain the data, efforts were unsuccessful. No study data are available

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

USSF