drugset / Trial / NCT01136772
A Comparison of Long-acting Injectable Medications for Schizophrenia
Phase 4
Completed
311 enrolled
New York State Psychiatric Institute
Duke University · collabNational Institute of Mental Health (NIMH) · collabUniversity of North Carolina, Chapel Hill · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this research study is to compare the "real-world" effectiveness of two FDA-approved and widely used long-acting injectable antipsychotic medications (paliperidone palmitate and haloperidol decanoate) in patients with schizophrenia or schizoaffective disorder who are expected to benefit from the improved medication compliance associated with injectable medications. The goal is to evaluate the effects of the medications on outcomes of importance to patients (relapse, symptoms, adverse effects, functioning) as well as policy makers (all of the above plus costs).
Timeline
- Start
- 2011-03
- Primary completion
- 2013-07
- Completion
- 2016-07
Publications
- Results McEvoy JP, Byerly M, Hamer RM, Dominik R, Swartz MS, Rosenheck RA, Ray N, Lamberti JS, Buckley PF, Wilkins TM, Stroup TS. Effectiveness of paliperidone palmitate vs haloperidol decanoate for maintenance treatment of schizophrenia: a randomized clinical trial. JAMA. 2014 May 21;311(19):1978-87. doi: 10.1001/jama.2014.4310.
- Results Rosenheck RA, Leslie DL, Sint KJ, Lin H, Li Y, McEvoy JP, Byerly MJ, Hamer RM, Swartz MS, Stroup TS. Cost-Effectiveness of Long-Acting Injectable Paliperidone Palmitate Versus Haloperidol Decanoate in Maintenance Treatment of Schizophrenia. Psychiatr Serv. 2016 Oct 1;67(10):1124-1130. doi: 10.1176/appi.ps.201500447. Epub 2016 Jun 1.
- Stroup TS, Bareis NA, Rosenheck RA, Swartz MS, McEvoy JP. Heterogeneity of Treatment Effects of Long-Acting Injectable Antipsychotic Medications. J Clin Psychiatry. 2018 Nov 27;80(1):18m12109. doi: 10.4088/JCP.18m12109.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Haloperidol Decanoate | Small molecule | 25 mg | Intramuscular |
| Comparator | Haloperidol Decanoate | Small molecule | 200 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 39 mg | Intramuscular |
| Subject | paliperidone palmitate | Unknown | 234 mg | Intramuscular |