drugset / Trial / NCT00330551
Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia
Phase 4
Completed
126 enrolled
University of California, Los Angeles
Janssen Scientific Affairs, LLC · collabNational Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.
Timeline
- Start
- 2006-03
- Primary completion
- 2012-11
- Completion
- 2012-11
Outcome
Mixed primary results
registry analysis (superiority test); Long-acting Injectable Risperidone vs Oral Risperidone; p =.001; Risk Difference (RD) 11.1; Chi-squared NCT00330551 ↗
registry analysis (superiority test); Long-acting Injectable Risperidone vs Oral Risperidone; p =.83; Chi-squared NCT00330551 ↗
Publications
- Subotnik KL, Casaus LR, Ventura J, Luo JS, Hellemann GS, Gretchen-Doorly D, Marder S, Nuechterlein KH. Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia. A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):822-9. doi: 10.1001/jamapsychiatry.2015.0270.
- Bartzokis G, Lu PH, Amar CP, Raven EP, Detore NR, Altshuler LL, Mintz J, Ventura J, Casaus LR, Luo JS, Subotnik KL, Nuechterlein KH. Long acting injection versus oral risperidone in first-episode schizophrenia: differential impact on white matter myelination trajectory. Schizophr Res. 2011 Oct;132(1):35-41. doi: 10.1016/j.schres.2011.06.029. Epub 2011 Jul 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risperidone | Other / unclassified | 25 mg | Other |
| Subject | Risperidone | Other / unclassified | — | Oral |