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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01359293
• Other study ID #: 200912770
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2011
• Last updated: May 23, 2011
• Start date: April 2011
• Est. completion date: December 2014

Study information

• Verified date: May 2011
• Source: University of Iowa
• Contact: Frank W Fleming, BS, BSN, RN
• Phone: 319-356-4719
• Email: frank-fleming[@]uiowa.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Schizophreniform

Intervention

Drug:
• paliperidone palmitate
injections given at day 1, 8, then monthly for a year.
• oral antipsychotics
haloperidol, palperidone, risperidone, perphenazine

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	Wishard Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to compare the effects of paliperidone vs. "standard treatment" on changes in brain parenchymal volume	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.	1 year	No
Secondary	: 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.	: 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.	1 year	No