Trial Outcomes & Findings for Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate (NCT NCT00593112)

Results Overview

Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS) This measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

after 6 weeks Concerta treatment

Results posted on

2012-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	OROS Methylphenidate OROS = Osmotic-controlled Release Oral delivery System	Control Healthy Volunteer Control group
Overall Study STARTED	27	12
Overall Study COMPLETED	17	12
Overall Study NOT COMPLETED	10	0

Reasons for withdrawal

Reasons for withdrawal
Measure	OROS Methylphenidate OROS = Osmotic-controlled Release Oral delivery System	Control Healthy Volunteer Control group
Overall Study Scan Anxiety	3	0
Overall Study Abnormal Scan	1	0
Overall Study Unreadable Scan	1	0
Overall Study Withdrawal by Subject	5	0

Baseline Characteristics

Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OROS Methylphenidate n=27 Participants OROS = Osmotic-controlled Release Oral delivery System	Control n=12 Participants Healthy Volunteer Control group	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	27 Participants n=93 Participants	12 Participants n=4 Participants	39 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	7 Participants n=4 Participants	25 Participants n=27 Participants
Region of Enrollment United States	27 participants n=93 Participants	12 participants n=4 Participants	39 participants n=27 Participants

PRIMARY outcome

Timeframe: after 6 weeks Concerta treatment

Population: Seven subjects who completed the protocol were not included due to a lack of baseline comparison.

Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS) This measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.

Outcome measures

Outcome measures
Measure	OROS Methylphenidate n=10 Participants OROS = Osmotic-controlled Release Oral delivery System	Control n=12 Participants Healthy Volunteer Control group
Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)	1.50 MRS Ratio Standard Deviation 0.45	1.56 MRS Ratio Standard Deviation 0.34

PRIMARY outcome

Timeframe: after 6 weeks Concerta treatment

Population: Seven subjects who completed the protocol were not included due to a lack of baseline comparison.

Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS) This measure is a ratio of Glutamine (amino acid precursor to Glu) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.

Outcome measures

Outcome measures
Measure	OROS Methylphenidate n=10 Participants OROS = Osmotic-controlled Release Oral delivery System	Control n=12 Participants Healthy Volunteer Control group
H MRS Scan Results - Glutamine (Gln)/Ino	1.08 MRS Ratios Standard Deviation 0.43	1.02 MRS Ratios Standard Deviation 0.60

PRIMARY outcome

Timeframe: after 6 weeks Concerta treatment

Population: Seven subjects who completed the protocol were not included due to a lack of baseline comparison.

Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS) This measure is a ratio of Glutamate and it's precursor, Glutamine, to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.

Outcome measures

Outcome measures
Measure	OROS Methylphenidate n=10 Participants OROS = Osmotic-controlled Release Oral delivery System	Control n=12 Participants Healthy Volunteer Control group
H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino	2.58 MRS Ratio Standard Deviation 0.73	2.59 MRS Ratio Standard Deviation 0.87

Adverse Events

OROS Methylphenidate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Paul Hammerness, M.D.

Massachusetts General Hospital

Phone: 617-503-1040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place