Parent-defined target symptoms respond to risperidone in RUPP autism study: Customer approach to clinical trials
| Autor: | Mark Davies, Elaine Tierney, Pegeen Cronin, Bhavik Shah, Lawrence Scahill, Christopher J. McDougle, L. Eugene Arnold, N. González, Donald J. McMahon, Shirley Chuang, Jill A. Hollway, Arlene E. Kohn, Kathleen Koenig, Michael G. Aman, Benedetto Vitiello |
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| Jazyk: | angličtina |
| Rok vydání: | 2003 |
| Předmět: |
Adult
Male Adolescent Endpoint Determination assessment autism Placebo Irritability Severity of Illness Index law.invention Placebos Double-Blind Method Randomized controlled trial law Severity of illness Developmental and Educational Psychology Pervasive developmental disorder medicine Humans Autistic Disorder Parent-Child Relations Child Observer Variation Clinical Trials as Topic Risperidone treatment medicine.disease pervasive developmental disorder instruments Aggression Clinical trial Affect Psychiatry and Mental health Treatment Outcome Research Design Dopamine Antagonists Autism Female Stereotyped Behavior medicine.symptom Psychology medicine.drug Clinical psychology |
| Popis: | A consumer-oriented efficacy assessment in clinical trials should measure changes in chief complaint and consumer request (symptoms of most concern to patient/caregiver), which may be diluted in change scores of multisymptom scales.In the Research Units on Pediatric Psychopharmacology (RUPP) Autism Network 8-week double-blind trial of risperidone versus placebo, the chief concerns of parents were collected at 0, 4, and 8 weeks (endpoint), in addition to standardized primary measures. Blinded clinical judges rated change from baseline to 4 and 8 weeks on a 9-point scale (1 = normalized, 5 = unchanged, 9 = disastrous); 94 participants had usable data.The most common symptoms identified by parents were tantrums, aggression, and hyperactivity. Interrater reliability was excellent. Mean ratings at endpoint were 2.8 +/- 1.2 on risperidone and 4.5 +/- 1.3 on placebo (p.001). Ratings were collinear with Clinical Global Impression-Improvement and Aberrant Behavior Checklist Irritability subscale (primary dimensional measure). Effect size d was 1.4, compared to 1.2 on the Aberrant Behavior Checklist Irritability subscale. Effect sizes varied twofold by symptom category, largest for self-injury (2.11) and tantrums (1.95).Risperidone was superior to placebo in reducing symptoms of most concern to parents of autistic children with irritable behavior. Rating individualized participant-chosen target symptoms seems a reliable, sensitive, efficient, and consumer-friendly way to assess treatment effect and might have clinical application. |
| Databáze: | OpenAIRE |
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