Trial Outcomes & Findings for Gene-environment Interactions and Brain Functional Connectivity in Attention Deficit Hyperactivity Disorder (NCT NCT01912352)

NCT ID: NCT01912352

Last Updated: 2014-12-04

Results Overview

Attendtion-deficit hyperactivity disorder (ADHD) Rating Scale-IV is the sum of 18 questions, ranging from 0 (no symptoms) to 54 (worst possible symptoms). Change from baseline ADHD Rating Scale-IV scores at 8 weeks was calculated as baseline minus 8 weeks.

Recruitment status

COMPLETED

Study phase

Target enrollment

83 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2014-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Methylphenidate Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
Overall Study STARTED	83
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gene-environment Interactions and Brain Functional Connectivity in Attention Deficit Hyperactivity Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methylphenidate n=83 Participants Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
Age, Continuous	9.5 years STANDARD_DEVIATION 2.6 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants
Region of Enrollment Korea, Republic of	83 participants n=5 Participants
Scores on the ADHD Rating Scale-IV	26.1 units on a scale STANDARD_DEVIATION 10.5 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Outcome measures

Outcome measures
Measure	Methylphenidate n=78 Participants Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks	14.9 units on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: baseline and 8 weeks

Clinical Global Impression-Improvement (CGI-I) scale is a one-item measure evaluating the change from the initiation of treatment on a seven-point scale: "Compared to the patient's condition at baseline \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Clinical Global Impression-Improvement was measured at 8 weeks.

Outcome measures

Outcome measures
Measure	Methylphenidate n=78 Participants Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
Clinical Global Impression-Improvement Scale at 8 Weeks	2.3 units on a scale Standard Deviation 0.7

Adverse Events

Methylphenidate

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Methylphenidate n=83 participants at risk Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
Nervous system disorders Headache	1.2% 1/83 • 8 weeks
Gastrointestinal disorders decreased appetite	43.4% 36/83 • 8 weeks
Gastrointestinal disorders stomach pain	1.2% 1/83 • 8 weeks
Gastrointestinal disorders Nausea	8.4% 7/83 • 8 weeks
Nervous system disorders Tiredness	1.2% 1/83 • 8 weeks
Psychiatric disorders Irritability	3.6% 3/83 • 8 weeks
Psychiatric disorders Trouble sleeping	10.8% 9/83 • 8 weeks
Psychiatric disorders Nail biting	2.4% 2/83 • 8 weeks
Psychiatric disorders Proness to crying	1.2% 1/83 • 8 weeks
Psychiatric disorders Tic	1.2% 1/83 • 8 weeks
Psychiatric disorders Depressive mood	1.2% 1/83 • 8 weeks
Psychiatric disorders Anxiety	1.2% 1/83 • 8 weeks
Psychiatric disorders Excitability	1.2% 1/83 • 8 weeks

Additional Information

Dr. Jae-Won Kim

Seoul National University

Phone: 822-2072-3648

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place