APPENDICES. A systematic review and economic model of the ...

Study Intervention Participants Outcomes
Core symptoms
ADHD Rating Scale IV: total score; inattentive
symptoms; hyperactive/impulsive symptoms
CPRS: hyperactivity
CTRS: hyperactivity
Inclusion criteria
1. 6–15 years of age
2. Symptom severity above 1.5 SD for age and gender
3. No bipolar disorder or psychotic illness
4. No unstable medical illness or condition that requires ongoing
psychoactive medication (other than ATX)
Arm 1
ATX
Mean dose: 1.56 mg/kg day;
administered twice daily
(Individuals administering medication
not reported)
References
Michelson et al., 2004; 75
Michelson et al.,
2003 315
Co-existent problems
CPRS: oppositional; cognitive problems
CTRS: oppositional; cognitive problems
Source
Updated search
Diagnostic criteria
DSM-IV
Number
Total randomised = 416 (male = 373)
Arm 1 = 292
Arm 2 = 124
Arm 2
Placebo
(Individuals administering medication
not reported)
Setting
International
Educational performance
Not reported
Design
Parallel trial
Psychological function
Not reported
Depression or anxiety
Not reported
Quality of life
CGI Severity of Illness scale
Child Health Questionnaire psychosocial
summary score
Total withdrawals = 10
Arm 1 = 9
Arm 2 = 1
Reasons for withdrawals:
All discontinuations were due to adverse events (9 in ATX group
and 1 in placebo group)
Duration
9 months
Purpose
To assess the efficacy of
ATX in preventing
relapse in paediatric
patients with ADHD
during 9 months after
an initial 12-week
treatment period
© Queen’s Printer and Controller of HMSO 2006. All rights reserved.
Adverse events
Some adverse events reported
Age
10 years (mean); 2.3 years (SD)
Health Technology Assessment 2006; Vol. 10: No. 23
Additional outcomes
Relapse prevention (symptom return to
≥ 90% baseline ADHD Rating Scale IV total
score and increase in CGI Severity of Illness
scale of at least 2 points)
IQ
Not reported
Co-morbid disorders
ODD: 43%, depression: 2%, generalised anxiety disorder: 3%
Diagnostic subtypes
Combined: 73%; hyperactive/impulsive: 5%; inattentive: 22%
Additional information
Previous medication:
The participants in this trial were children who responded to an
initial 12-week open-label period of treatment with ATX.
Patients who relapsed during the 9-month period were removed
from the study and offered the option of entering an open-label
extension of the study
Concurrent medication:
No participants were to be in receipt of ongoing psychoactive
medication (other than ATX) for an unstable medical illness or
condition
305