Trial record 1 of 3 for:
paliperidone | United States, Iowa
Effects of Paliperidone Palmitate Versus Oral Antipsychotics on Clinical Outcomes and MRI Measures
This study is currently recruiting participants.
Verified May 2011 by University of Iowa
Sponsor:
University of Iowa
Collaborator:
Wishard Health Services
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT01359293
First received: May 20, 2011
Last updated: May 23, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia Schizophreniform |
Drug: paliperidone palmitate Drug: oral antipsychotics |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
| Official Title: | Effects of Paliperidone Palmitate Versus Oral Antipsychotics on Clinical Outcome and sMR Measures in First Episode Patients: A Randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by University of Iowa:
Primary Outcome Measures:
- The primary objective of this study is to compare the effects of paliperidone vs. "standard treatment" on changes in brain parenchymal volume [ Time Frame: 1 year ] [ Designated as safety issue: No ]Null Hypothesis 1: During a 1 year follow up period, brain parenchymal (tissue) loss in persons recently diagnosed with schizophrenia who are treated with paliperidone palmitate is not different from that seen in similar patients treated with oral antipsychotic treatment as measured by sMR.
Secondary Outcome Measures:
- : To conduct a comparison study of the effects of paliperidone vs "oral antipsychotic treatment" on brain structure as measured using MR scanning in the two treatment groups and versus normal controls. [ Time Frame: 1 year ] [ Designated as safety issue: No ]: Patients in both treatment groups will have progressive decreases in frontal lobe GM, WM, and in frontal lobe FA that are significantly greater than changes occurring in the normal controls. They will also have reduced intensity and extent of BOLD effect in prefrontal cortex and overall reduction in functional connectivity in the default network as measured with fMR during the default state.
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Injectible antipsychotic
Paliperidone palmitate injections
|
Drug: paliperidone palmitate
injections given at day 1, 8, then monthly for a year.
Other Name: Sustenna
|
|
Active Comparator: Oral antipsychotics
The standard treatments will be one of four oral medications: risperidone, oral paliperidone, haldol,or perphenzine.
|
Drug: oral antipsychotics
haloperidol, palperidone, risperidone, perphenazine
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients with a DSM-IV diagnosis of schizophrenia or schizophreniform disorder
- Age range 18-40
- Ability to provide informed consent
- First episode (first hospital admission) or recent onset (no more than five years since onset of first psychotic symptom) -
Exclusion Criteria:
- Substance dependence either currently or during the month prior to entry (except caffeine and nicotine)
- Unstable medical conditions
- Pregnant or lactating women
- Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculoperitoneal shunt (because of MR studies).
- IQ less than 70 -
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359293
Contacts
| Contact: Frank W Fleming, BS, BSN, RN | 319-356-4719 | frank-fleming@uiowa.edu |
Locations
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Frank W Fleming, BS, BSN, RN 319-356-4719 frank-fleming@uiowa.edu | |
| Principal Investigator: Nancy C Andreasen, MD, PhD | |
Sponsors and Collaborators
University of Iowa
Wishard Health Services
Investigators
| Principal Investigator: | Nancy C Andreasen, MD, PhD | University of Iowa Hospital and Clinics |
More Information
No publications provided
| Responsible Party: | Nancy C Andreasen MD, PhD, University of Iowa Hospitals and Clinics |
| ClinicalTrials.gov Identifier: | NCT01359293 History of Changes |
| Other Study ID Numbers: | 200912770 |
| Study First Received: | May 20, 2011 |
| Last Updated: | May 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
9-hydroxy-risperidone Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 22, 2013