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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by University of Iowa
Sponsor:
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
  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:

  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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
9-hydroxy-risperidone
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 September 18, 2014