Prospective trial of Risperdal following psychological therapy for challenging behaviour in learning disabled children
| DEC-NET Serial number GB289 | |
| Published online | 13/07/2004 13.40.00 |
| Last updated | 28/02/2006 13.53.09 |
| Other protocol ID number | N0266126287 |
| This trial has been approved by an ethics committee | |
| Current trial status | Open (actively recruiting new participants) |
| Major Disease (ICD9 class) | UNSPECIFIED DISTURBANCE OF CONDUCT |
| Experimental drug | |
| Risperidone | |
| Gender | Both |
| Age (range) | 5-16 years |
Eligibility criteria | |
| Inclusion criteria | |
| 20 children ages 5 -16 with selection criteria | |
| Exclusion criteria | |
| Children not having undergone psychological therapy Children not exhibiting challenging behaviour | |
Trial design/methodology | |
| Phase | 4 |
| Kind of study | Efficacy Safety |
| Design | Prospective, Comparative |
| Purpose of study | |
| To effect an assessment of the safety of oral Risperdal in behaviour disorder in mild, moderate and severe mentally retarded children. | |
| Primary outcomes | |
| 35% diminution in abberant behaviour checklist Diminution in hostility checklist | |
| Secondary outcomes | |
| Significant increase in quality of life rating scale | |
| Summary of study design, objectives, and ongoing research findings | |
| Open, prospective, comparative study to effect an assessment of the safety of oral Risperdal in behaviour disorder in mild, moderate and severe mentally retarded children. | |
| Principal investigator | |
| Name | Professor Stephen Read |
| Institution | University of Huddersfield |
| Postal address | University of Huddersfield, R 1/9 Ramsden Building, Queensgate, Huddersfield, HD1 3DH |
| City | Huddersfield |
| Country | UNITED KINGDOM |
| Phone | 01484 473496 |
| Fax | 01484 473760 |
| s.read@hud.ac.uk | |
| Sponsor name |
| Janssen-Cilag (Industry) |
| ISRCTN | EudraCT |
