This trial is active, not recruiting.

Conditions schizophrenia, schizoaffective disorder
Treatments haloperidol decanoate, paliperidone palmitate
Phase phase 4
Sponsor New York State Psychiatric Institute
Collaborator National Institute of Mental Health (NIMH)
Start date March 2011
End date July 2013
Trial size 311 participants
Trial identifier NCT01136772, #6017, R01MH081107


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Intramuscular injections of paliperidone palmitate 39-234 mg every month
paliperidone palmitate Invega Sustenna
Paliperidone palmitate injections, 39 mg - 234 mg once a month
(Active Comparator)
Intramuscular injections of haloperidol decanoate 25-200 mg every month
haloperidol decanoate Haldol
haloperidol decanoate injections, 25-200 mg once a month

Primary Outcomes

Efficacy Failure
time frame: 24 months

Secondary Outcomes

Changes in Psychiatric Symptoms
time frame: Baseline to 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Comparison of Long-Acting Injectable Medications for Schizophrenia
Principal investigator Scott Stroup, MD, MPH
Description The purpose of this comparative effectiveness research study is to learn more about different medications called antipsychotics that are used to treat schizophrenia or schizoaffective disorder. Specifically, we are looking at long-acting medications that are given by injection every month, instead of being taken by mouth every day. In this multi-site study, we are comparing the risk and benefits of two FDA-approved long-acting injectable medications (paliperidone palmitate and haloperidol decanoate). Study participants with schizophrenia or schizoaffective disorder are expected to benefit from the improved medication schedule. This study aims to enroll 360 individuals with schizophrenia or schizoaffective disorder for whom treatment with a long-acting injectable antipsychotic medication is likely to be helpful. Study participants will be randomly assigned to treatment with either paliperidone palmitate and haloperidol decanoate for up to 24 months. Participants will have an equal chance of being assigned to each medication, however participants will not know which medication they are taking.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by New York State Psychiatric Institute.