Effects of Paliperidone Palmitate Versus Oral Antipsychotics on Clinical Outcomes and MRI Measures



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 40
Updated:4/2/2016
Start Date:April 2011
End Date:December 2014
Contact:Frank W Fleming, BS, BSN, RN
Email:frank-fleming@uiowa.edu
Phone:319-356-4719

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Trial Summary
Trial Overview
Inclusion Criteria

Effects of Paliperidone Palmitate Versus Oral Antipsychotics on Clinical Outcome and sMR Measures in First Episode Patients: A Randomized Clinical Trial

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.

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.

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 -
We found this trial at
1
site
University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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