Trial Outcomes & Findings for Neuroimaging of the Effects of Concerta in the Treatment of ADHD (NCT NCT00778310)

NCT ID: NCT00778310

Last Updated: 2012-07-13

Results Overview

Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 76 participants
• Primary outcome timeframe: Placebo and Drug day, 1-2 weeks apart
• Results posted on: 2012-07-13

Participant Flow

A total of 75 patients were enrolled from 11/4/2008 t0 8/12/2010. Patients were recruited from advertisements in local papers as well as flyers in the UTHSCSA psychiatric clinic.

Psychiatric assessment was performed to confirm the diagnosis of ADHD. Fifteen (15) patients were screen failures. Five (5) patients did not respond to an open label trial of Concerta were excluded. 11 withdrew consent or lost to follow up. (1) withdrew to claustrophobia. 43 were exposed to study drug (Concerta and placebo) in crossover design.

Participant milestones

Measure	Adults These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.	Children These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.
Overall Study STARTED	17	26
Overall Study Usable Data	14	21
Overall Study COMPLETED	17	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuroimaging of the Effects of Concerta in the Treatment of ADHD

Baseline characteristics by cohort

Measure	Adults n=17 Participants These were participants between the age of 21-25 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.	Children n=26 Participants These were participants between the age of 3- 17 years. They underwent 2 FMRI studies, once on placebo and once on Concerta in a double blind randomized crossover design.	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	26 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	0 Participants n=7 Participants	17 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	22.2 years STANDARD_DEVIATION 1.78 • n=5 Participants	11.3 years STANDARD_DEVIATION 2.1 • n=7 Participants	15.6 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	26 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Placebo and Drug day, 1-2 weeks apart

Population: The number who completed both fMRI one week apart (crossover study, scanned twice

Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials.

Outcome measures

Measure	Adults Drug Condition n=14 Participants This is the BOLD signal data on the Concerta day scan.	Adults Placebo Condition n=14 Participants This is the BOLD signal data on the Placebo day scan.	Children Drug Condition n=21 Participants This is the BOLD signal data on the Concerta day scan.	Children Placebo Condition n=21 Participants This is the BOLD signal data on the Placebo day scan.
Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo Amygdala	1.79 Face-Shape BOLD signal difference Standard Deviation 1.06	0.58 Face-Shape BOLD signal difference Standard Deviation 1.09	1.43 Face-Shape BOLD signal difference Standard Deviation 1.08	0.77 Face-Shape BOLD signal difference Standard Deviation 1.36
Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo Fusiform Gyrus	1.46 Face-Shape BOLD signal difference Standard Deviation 1.36	1.64 Face-Shape BOLD signal difference Standard Deviation 1.21	1.99 Face-Shape BOLD signal difference Standard Deviation 1.1	1.06 Face-Shape BOLD signal difference Standard Deviation 1.12

Adverse Events

Adults

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Children

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

Steven R. Pliszka MD

University of Texas Health Science Center at San Antonio

Phone: 210-567-5475

Email: pliszka@uthscsa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place