A Comparison of Long-acting Injectable Medications for Schizophrenia

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborators: Duke University; National Institute of Mental Health (NIMH); University of North Carolina, Chapel Hill
• Treatments: Decanoic acid; Haloperidol; Haloperidol decanoate; Paliperidone Palmitate

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