Phase 4
Completed N=311
A Comparison of Long-acting Injectable Medications for Schizophrenia
Source: ClinicalTrials.gov NCT01136772 ↗Enrolled (actual)
311
Serious AEs
33.3%
Results posted
Apr 2015
Primary outcomePrimary: Efficacy Failure — 49; 47 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Failure |
49; 47 | — |
| SECONDARY Changes in Psychiatric Symptoms |
-6.87; -6.40 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria
- Age 18-65 years
- Capacity to provide informed consent
- Patients who are likely to benefit from treatment with long-acting injectable paliperidone palmitate or haloperidol decanoate
- Women of child bearing potential must have a negative serum pregnancy test at the Screening Visit.
Exclusion Criteria
- Patients who are currently stable and doing well on an antipsychotic regimen
- Patients not expected to benefit from the study medications due to past experience with risperidone, paliperidone or haloperidol
- Patients with tardive dyskinesia that is moderate or severe
- Patients with any medical condition that, in the judgment of the investigator, might preclude safe completion of the study
- Women who are pregnant or breastfeeding
- Patients with mental retardation
Data sourced from ClinicalTrials.gov (NCT01136772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.