View Clinical Trial (Medical Research Study)
Effects of Paliperidone Palmitate Versus Oral Antipsychotics on Clinical Outcome and sMR Measures in First Episode Patients: A Randomized Clinical Trial
| City: |
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Iowa City |
| State: |
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Iowa |
| Zip Code: |
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52242 |
| Conditions: |
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Schizophrenia - Schizophreniform |
| Purpose: |
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The primary objective of this study is to compare the effects of paliperidone versus oral
antipsychotics on changes in brain parenchymal volume, number of relapses, and time to
relapse during a one-year period of follow up of patients with new onset schizophrenia.
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| Study Summary: |
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Subjects will participate in 1 year of treatment with 3 MRI scans at six month intervals.
Side effects and metabolic measures will be followed over the course of the study.
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| Criteria: |
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Inclusion Criteria:
1. Patients with a DSM-IV diagnosis of schizophrenia or schizophreniform disorder
2. Age range 18-40
3. Ability to provide informed consent
4. First episode (first hospital admission) or recent onset (no more than five years
since onset of first psychotic symptom) -
Exclusion Criteria:
1. Substance dependence either currently or during the month prior to entry (except
caffeine and nicotine)
2. Unstable medical conditions
3. Pregnant or lactating women
4. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS
unit, or ventriculoperitoneal shunt (because of MR studies).
5. IQ less than 70 -
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| NCT ID: |
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NCT01359293 |
| Primary Contact: |
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Principal Investigator
Nancy C Andreasen, MD, PhD
University of Iowa Hospital and Clinics
Frank W Fleming, BS, BSN, RN
Phone: 319-356-4719
Email: frank-fleming@uiowa.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Iowa City, Iowa 52242
United States
Frank W Fleming, BS, BSN, RN
Phone: 319-356-4719
Email: frank-fleming@uiowa.edu
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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