Trial Outcomes & Findings for Brain Dopamine Function in Adults With ADHD (NCT NCT00580814)

Last Updated: 2024-08-29

Results Overview

Striatal DAT availability as noted in PET scans post one year of methylphenidate treatment or no intervention. The unit listed as binding potential (BPND) was measured with a dynamic PET scan protocol, using carbon-11 labeled cocaine, a radioligand with specific binding to DAT (which is inhibited by drugs that block DAT but not by drugs that block the norephephrine or serotonin transporters). This radiotracer was utilized to quantify DAT availability as non-displaceable binding potential using a standard kinetic model for reversible ligands. The dynamic PET scans were started immediately after injection of \[11C\]cocaine (specific activity 0.5-1.5 Ci/uM at end of bombardment). Arterial blood was obtained to measure the concentration of unchanged \[11C\] cocaine in plasma for quantification of DAT availability.

Recruitment status

COMPLETED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

1 year

Results posted on

2024-08-29

Participant Flow

Subjects were recruited at 3 sites from 2004 - 2008. They were all consented to the protocol before any study procedures were done.Subjects were recruited through flyers and newspaper ads. They were seen at medical clinics and ADHD diagnosis was confirmed. All subjects were treatment naive for stimulant medications.

Subjects were interviewed to determine mental health diagnosis of ADHD with symptoms existing since childhood. All other psychiatric diagnoses were exclusionary as was neurological or cerebral disease. Healthy controls were also recruited. All subjects were then scheduled for scans at Brookhaven and ADHD subjects then recieved one year of meds.

Participant milestones

Participant milestones
Measure	Methylphenidate Treatment methylphenidate treatment methylphenidate : Subjects (18) in this arm recieved methylphenidate for one year.	no Intervention no intervention for 12 months no intervention : no treatment for 11 subjects for 12 months
Baseline PET Scans at Brookhaven STARTED	55	20
Baseline PET Scans at Brookhaven COMPLETED	55	20
Baseline PET Scans at Brookhaven NOT COMPLETED	0	0
One Year of Treatment or no Intervention STARTED	55	20
One Year of Treatment or no Intervention COMPLETED	18	11
One Year of Treatment or no Intervention NOT COMPLETED	37	9
Repeated PET Scans STARTED	18	11
Repeated PET Scans COMPLETED	18	11
Repeated PET Scans NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Dopamine Function in Adults With ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methylphenidate Treatment n=55 Participants methylphenidate treatment methylphenidate : Subjects (18) in this arm recieved methylphenidate for one year.	no Intervention n=20 Participants no intervention for 12 months no intervention : no treatment for 11 subjects for 12 months	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants	20 Participants n=7 Participants	75 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.9 years STANDARD_DEVIATION 1.9 • n=5 Participants	33.2 years STANDARD_DEVIATION 1.6 • n=7 Participants	31.5 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	12 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	8 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants	20 participants n=7 Participants	75 participants n=5 Participants
PET scan of DAT availability	55 participants n=5 Participants	20 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: DAT availability was measured as ratio of distribution volume in striatum to cerebellum -1 (BPND-1), which represents number of transporters free to bind radiotracer. Distribution volume ratio images were transformed into images by computing total distribution volume in each pixel and dividing by distribution volume in cerebellum. Regions of interest in striatum (caudate, putamen, ventral striatum) were drawn on an averaged emission image (10 to 60 minutes for \[11C\] cocaine).

Outcome measures

Outcome measures
Measure	Methylphenidate Treatment n=18 Participants methylphenidate treatment methylphenidate : Subjects (18) in this arm recieved methylphenidate for one year.	no Intervention n=11 Participants no intervention for 12 months no intervention : no treatment for 11 subjects for 12 months
DAT Availability	2.68 ratio Standard Deviation 0.28	2.85 ratio Standard Deviation 0.31

Adverse Events

Methylphenidate Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tim Wigal, Ph.D., director UCI CHild Development Center

UCaliforniaIrvine

Phone: 949-824-1812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place