Akhondzadeh et al., 2008

Study DescriptionInterventionInclusion/Exclusion
Criteria/Population
Baseline MeasuresOutcomes
Author:
Akhondzadeh et al., 2008
Country:
Iran
Practice setting:
Academic
Intervention setting:
Clinic
Enrollment period:
NR
Funding:
NR
Author industry relationship disclosures:
NR
Design:
RCT, double blind, placebo controlled
Intervention:
Piracetam, titrated up to 800 mg/day (200 mg/day starting dose with 200 mg increments every 2 days) Risperidone, dosage by weight:
  • 10–40 kg: titrated up to 2 mg/day fixed dose (0.5 mg starting dose with 0.5 mg increments in weekly dose for first 3 weeks)
  • > 40 kg: titrated up to 3 mg/day fixed dose
Duration: 10 weeks
Assessments:
ABC-C, Extrapyramidal Symptoms Rating Scale administered by blinded rater in clinic
Groups:
G1: piracetam + risperidone
G2: placebo + risperidone
Co-interventions held stable during treatment:
NA
Frequency of contact during study:
Ratings at weeks 0, 2, 4, 6, 8, and 10
Concomitant therapies:
NR
N at enrollment:
G1: 20
G2: 20
N at follow-up:
G1: 20
G2: 20
Inclusion criteria:
  • Age 3–11 years
  • Diagnosis of autism
Exclusion criteria:
  • Previously received neuroleptics or any psychotropic drug treatment 6 months prior to recruitment
  • Significant active medical problem
  • Children without definitive diagnosis of autism as in severe/profound mental retardation
Age, years ± SD (range):
G1: 6.9 ± 1.86 (3–11)
G2: 6.75 ± 1.8 (3–11)
Mental age:
NR
Gender, n (%):
Male:
G1: 16 (80)
G2: 14 (70)
Female:
G1: 4 (20)
G2: 6 (30)
Race/ethnicity:
NR
SES:
Maternal education: NR
Household income: NR
Diagnostic approach:
In-study confirmation
Diagnostic tool/method:
Semistructured interview with a score of ≥ 6 on the DSM-IV diagnosis criteria and clinical evaluation
Diagnostic category, n (%):
Autism: 40 (100)
Other characteristics, n:
Extrapyramidal symptoms:
G1: 6
G2: 8
G1/G2: P = 0.74
Problem behavior:
ABC-C total score, mean ± SD:
G1: 23.15 ± 5.80
G2: 24.00 ± 8.25
G1/G2: P = 0.70
Problem behavior:
ABC-C total score, week 10, mean change ± SD:
G1: −11.9 ± 3.79
G2: −5.15 ± 3.04
G1/G2: P < 0.0001
Harms:
Treatment-related AEs, n (%):
Constipation:
G1: 4 (20)
G2: 3 (15)
G1/G2: P = NS
Nervousness:
G1: 1 (5)
G2: 2 (10)
G1/G2: P = NS
Daytime drowsiness:
G1: 7 (35)
G2: 9 (45)
G1/G2: P = NS
Morning drowsiness:
G1: 11 (55)
G2: 8 (40)
G1/G2: P = NS
Increased appetite:
G1: 7 (30)
G2: 6 (30)
G1/G2: P = NS
Dry mouth:
G1: 4 (20)
G2: 3 (15)
G1/G2: P = NS
Fatigue:
G1: 5 (25)
G2: 3 (15)
G1/G2: P = NS
Loss of appetite:
G1: 1 (5)
G2: 1 (5)
G1/G2: P = NS
Modifiers:
NR

From: Appendix C, Evidence Tables

Cover of Therapies for Children With Autism Spectrum Disorders
Therapies for Children With Autism Spectrum Disorders.
Comparative Effectiveness Reviews, No. 26.
Warren Z, Veenstra-VanderWeele J, Stone W, et al.

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