Sandler 1999.
Methods | Parallel trial of single‐dose secretin versus single‐dose placebo |
Participants | Inclusion criteria:
Location/setting: Department of Psychiatry, University of North Carolina. Children were referred by the Treatment and Evaluation of Autism and Communication Handicaps program of the Department of Psychiatry at the University of North Carolina or whose parents responded to notices about this study placed in the newsletter of an autism‐support group. Sample size: 60 children were randomised Number of withdrawals/dropouts: 4 could not be evaluated (2 received secretin outside the study, and 2 did not return for follow‐up) Gender: not reported Mean age: secretin 7.6 years, placebo 7.4 years IQ: secretin 65.6, placebo 60.1 Baseline ABC‐I or other BoC: not reported Concomitant medications: secretin 8/30, placebo 11/30 were taking psychotropic medications History of previous medications: not reported |
Interventions | Intervention (single‐dose secretin): 0.4 ug per kg of body weight Comparator (single‐dose placebo): saline placebo |
Outcomes | Primary outcomes:
Secondary outcomes: none reported Timing of outcome assessments: baseline, weeks 1, 2 and 4 postinfusion |
Notes | Study start date: not reported Study end date: not reported Source of funding: Thoms Health Services Foundation and by a Public Health Service grant (30615) from the National Institutes of Child Health and Human Development Conflicts of interest: none declared Comment: study author contacted twice for information about AEs but no reply |