Trial Outcomes & Findings for Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD (NCT NCT00585910)

Results Overview

The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

94 participants

Primary outcome timeframe

7 weeks

Results posted on

2012-11-14

Participant Flow

Subjects were recruited for this study from Outpatient Psychiatry Clinics, the Clinical Pediatric Psychopharmacology Unit of the MGH, and the MGH's extensive network of partnered institutions. Subjects were recruited from 2004 through 2007.

Some reasons as to why subjects were excluded from the trial before baselining include: being found ineligible, withdrawing consent, and being lost to follow-up.

Participant milestones

Participant milestones
Measure	Overall Study Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
Atomoxetine (ATMX) Alone STARTED	72
Atomoxetine (ATMX) Alone COMPLETED	55
Atomoxetine (ATMX) Alone NOT COMPLETED	17
ATMX + Osmotic-Release Methylphenidate STARTED	50
ATMX + Osmotic-Release Methylphenidate COMPLETED	41
ATMX + Osmotic-Release Methylphenidate NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=72 Participants Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
Age, Categorical <=18 years	72 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	9.1 years STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 weeks

Population: All analyses were intent to treat, with last observation carried forward.

The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).

Outcome measures

Outcome measures
Measure	Overall Study n=50 Participants Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)	12.8 Units on a Scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: 7 weeks

Secondary analyses allowed us to evaluate the effects of treatment on additional measures of functioning (CGIs for ADHD and other psychiatric disorders). The CGI-Severity scale is as follows: 0 = Not assessed, 1 = normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, 7 = Among the most extremely ill patients.

Outcome measures

Outcome measures
Measure	Overall Study n=50 Participants Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders	2.7 Units on a Scale Interval 2.7 to 3.7

Adverse Events

ATMX Only

Serious events: 0 serious events

Other events: 72 other events

Deaths: 0 deaths

ATMX and OROS MPH

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ATMX Only n=72 participants at risk Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase.	ATMX and OROS MPH n=50 participants at risk Partial responders to ATMX alone entered into the ATMX and OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
Gastrointestinal disorders Loss of Appetite	19.4% 13/67	44.0% 22/50
Gastrointestinal disorders Gastro-Intestinal	50.7% 34/67	34.0% 17/50
General disorders Insomnia	14.9% 10/67	50.0% 25/50
General disorders Headaches	28.4% 19/67	22.0% 11/50
Psychiatric disorders Irritability	16.4% 11/67	32.0% 16/50
General disorders Fatigue	43.3% 29/67	6.0% 3/50
General disorders Rhinitis	25.4% 17/67	22.0% 11/50

Additional Information

Kerry Brodziak

Massachusetts General Hospital

Phone: 617-503-1043

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place