Nagaraj et al., 2006

Study DescriptionInterventionInclusion/Exclusion
Criteria/Population
Baseline MeasuresOutcomes
Author:
Nagaraj et al., 2006
Country:
India
Practice setting:
Academic
Intervention setting:
Pediatric neuro-development clinic
Enrollment period:
January 2002 to December 2003
Funding:
Postgraduate Institute of Medical Education and Research, Chandigarh
Author industry relationship disclosures:
NR
Design:
RCT, block randomization, double blind study
Intervention:
Liquid suspension risperidone or placebo, 0.5 mg/day orally for two weeks then 1 mg/day for the remaining 6 months
Assessments:
CARS, CGAS conducted by investigator at intake and every 8 weeks for 6 months
Parent questionnaire designed for study
Groups:
G1: risperidone
G2: placebo
Co-interventions held stable during treatment:
Yes (psychoactive medications stopped 1 month in advance of entering trial; no other drugs administered concurrently except antiepileptics); non-medical interventions not reported
Frequency of contact during study:
Every 8 weeks
Concomitant therapies:
NR
N at enrollment:
G1: 19
G2: 21
N at follow-up:
G1: 19
G2: 20
Inclusion criteria:
  • Age ≤12 years
  • Diagnosed with autism according to DSM IV criteria
Exclusion criteria:
  • Severe mental retardation
  • Significant co-existing disease/illness
  • Severe malnutrition (weight for age < 60% of NCHS median)
Age, months ± SD:
G1: 57.95 ± 20.84
G2: 63.0 ± 20.12
Mental age:
NR
Gender, n (%): Male:
G1: 16 (84.2)
G2: 18 (90)
Female:
G1: 3 (15.8)
G2: 2 (10)
Race/ethnicity:
NR
SES:
Maternal education: NR Socioeconomic class, n (%):
Very high:
G1: 3 (15.8)
G2: 6 (30)
Upper middle:
G1: 10 (52.6)
G2: 5 (25)
Middle:
G1: 5 (26.3)
G2: 8 (40)
Lower middle:
G1: 1 (5.3)
G2: 1 (5)
Diagnostic approach:
NR
Diagnostic tool/method:
Clinical interview, DSM-IV
Overall Ratings:
CARS score, median (range):
G1: 39.5 (32.5–46)
G2: 38.5 (31.5–43)
CGAS score, mean ± SD:
G1: 29.79 ± 7.27
G2: 32.65 ± 7.95
IQ, n (%):
Borderline IQ:
G1: 9 (47.4)
G2: 8 (40)
Mild retardation:
G1: 6 (31.6)
G2: 5 (25)
Moderate retardation:
G1: 4 (21.1)
G2: 7 (35)
VABS social maturity score, mean ± SD:
G1: 61.92 ± 16.16
G2: 60.64 ± 19.31
Communication/ language, n (%):
Simple sentences:
G1: 3 (16)
G2: 2 (10)
Few meaningful words:
G1: 5 (26.3)
G2: 5 (25)
Imitate speech sounds only:
G1: 7 (36.8)
G2: 7 (35)
Nonverbal communication:
G1: 2 (10.5)
G2: 5 (25)
No communication:
G1: 2 (10.5)
G2: 1 (5)
Medical:
Weight, mean kg ± SD:
G1: 16.17 ± 3.38
G2: 18.25 ± 5.6
Previous medication, n (%):
None:
G1: 15 (79)
G2: 16 (80)
Overall Ratings:
CARS score, median (range):
G1: 32.0 (24.5–40.5)
G2: 37.5 (30–42.5)
G1/G2: P < 0.001
CARS score ≥ 20% improvement from baseline:
G1: 12/19
G2: 0/20
CGAS score, mean ± SD:
G1: 40.94 ± 7.83
G2: 35.2 ± 9.38
G1/G2: P = 0.035
CGAS score ≥ 20% improvement from baseline:
G1: 17/19
G2: 2/20
Parent impresssions, global, n: Considerably improved:
G1: 9/19
G2: 0/20
Improved to some extent:
G1: 9/19
G2: 6/20
No change:
G1: 0/19
G2: 9/20
Worsened:
G1: 1/19
G2: 4/20
G1/G2: P = NS
Social skills:
Parent impresssions, social responsiveness, n:
Significantly improved:
G1: 7/19
G2: NR
G1/G2: P = 0.014
Diagnostic category, n (%):
Autism: 39 (100)
Other characteristics, n (%):
Lack of eye contact, gestures, other non-verbal communication:
G1: 16 (84.2)
G2: 19 (95)
Impaired peer relation-ships, reciprocity, sharing emotions:
G1: 19 (100)
G2: 19 (95)
Total lack of spoken language:
G1: 12 (63.2)
G2: 16 (80)
Impaired general linguistic ability, comprehension:
G1: 19 (100)
G2: 20 (100)
Impaired imaginative play:
G1: 12 (63.2)
G2: 15 (75)
Restricted pattern of interests:
G1: 14 (73.7)
G2: 12 (60)
Inflexible adherence to routine, stubbornness:
G1: 10 (52.6)
G2: 7 (35)
Motor and verbal stereotypies:
G1: 13 (68.4)
G2: 11 (55)
Hyperactivity:
G1: 12 (63.2)
G2: 14 (70)
Aggressive behavior, tantrums:
G1: 9 (47.4)
G2: 11 (55)
Irritability:
G1: 17 (89.5)
G2: 19 (95)
Withdrawal, inattention:
G1: 10 (52.6)
G2: 10 (50)
Self-injurious behavior:
G1: 7 (36.8)
G2: 5 (25)
Antipsychotic:
G1: 3 (16)
G2: 1 (5)
Stimulant:
G1: 1 (5)
G2: 3 (15)
Problem behavior:
Parent impresssions, decreased hyperactivity, n:
Significantly improved:
G1: 7/19
G2: NR
G1/G2: P = 0.002
Parent impresssions, aggression and irritability, n:
Significantly improved:
G1: 5/19
G2: NR
G1/G2: P = 0.016
Communication/ language:
Parent impresssions, nonverbal communication, n:
Significantly improved:
G1: 8/19
G2: NR
G1/G2: P = 0.008
Adaptive behavior:
Increased appetite/improved eating habits, n:
G1: 17/19
G2: NR
Medical:
Weight, mean change kg ± SD:
G1: 2.81 ± 2.04
G2: 1.71 ± 1.3
Harms:
Mild Sedation:
G1: 4/19
G2: NR
Dyskinesias:
G1: 3/19
G2: NR
Drooling:
G1: 1/19
G2: NR
Modifiers:
NR
Seizures:
G1: 5 (26.3)
G2: 3 (15)
Family structure, n (%):
Nuclear:
G1: 13 (68.4)
G2: 15 (75)
Joint:
G1: 6 (31.6)
G2: 5 (25)

Comments:

*

(orolingual=2, left lower limb=1)

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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