NCT01109147

Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients

Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients During Emotional Tasks and With Reference to Controls

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Qualissima · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

After an initial screening visit, including an assessment of psychiatric disorders, patients stabilized on antipsychotic medication (aripiprazole or risperidone) for at least 6 weeks and control subjects will undergo an assessment using functional magnetic resonance imaging (fMRI) of the differences of patterns of brain activation during an emotional task

Detailed description

This study is: interventional, comparative, open label, multi center, without experimental treatment. Main objective: To evaluate the effect of aripiprazole and risperidone on brain activation during an emotional task of matching patients with schizophrenia, and in reference to control subjects. Secondary Objective: Comparison of emotional subjective and physiological perception in patients with schizophrenia in relation with their treatment. Comparison of brain activation in patients during the emotional induction task based on symptomatic dimensions, personality traits and performance on cognitive and attentional tests, and for insight capacity . Comparison of transcript level of candidate genes in blood mononuclear cells between the study groups and study the interactions between the observed differences in brain imaging and different levels of transcription of these genes.

Conditions

• Schizophrenia, Undifferentiated Type

Interventions

Type	Name	Description
OTHER	Imagery	All the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination.
GENETIC	pharmacogenetic sampling	A pharmacogenetic sample will be done with an additional consentment.

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-01-01
• Completion: 2013-05-01
• First posted: 2010-04-23
• Last updated: 2014-04-09
• Results posted: 2014-04-09

Locations

2 sites across 1 country: France