drugset / Trial / NCT00859872
Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia
Phase 4
Completed
198 enrolled
Central South University
Capital Medical University · collabChongqing Mental Hospital · collabGuangzhou Mental Hospital · collabShanghai Mental Health Center · collabWuhan Mental Health Centre · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment sessions, parallel-group study. After screening period, eligible subjects will be entered 5 days treatment session I to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation, then will be followed by 6 additional weeks treatment session II for exploring the effect of medicine switching from IM injection to oral.
Timeline
- Start
- 2008-08
- Primary completion
- 2009-03
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clonazepam | Small molecule | 4 mg | Oral |
| Subject | Clonazepam | Small molecule | 8 mg | Oral |
| Comparator | Haloperidol | Other / unclassified | 5 mg | Intramuscular |
| Comparator | Haloperidol | Other / unclassified | 20 mg | Intramuscular |
| Subject | Risperidone | Other / unclassified | 2 mg | Oral |
| Subject | Risperidone | Other / unclassified | 6 mg | Oral |