A Comparison of Long-Acting Injectable Medications for Schizophrenia
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| City: |
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Waco |
| State: |
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Texas |
| Zip Code: |
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78711 |
| Conditions: |
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Schizophrenia - Schizoaffective Disorder |
| Purpose: |
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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).
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01136772 |
| Primary Contact: |
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Principal Investigator
Scott Stroup, MD, MPH
Columbia University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Waco, Texas 78711
United States
Christine Kuhn
Phone: 254-297-3954
Email: Christine.Kuhn@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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