Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients
Condition: Schizophrenia, Undifferentiated Type
MeSH terms: Schizophrenia
Intervention: Imagery; pharmacogenetic sampling
Intervention description: All the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination.; A pharmacogenetic sample will be done with an additional consentment.
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Schizophrenic Disorders; Schizophrenia; Affect; Emotional Blunting

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  For patients

               1. Men and women, right handed, 18 to 45 years;

               2. Having given their written informed consent;

               3. Presenting a diagnosis of schizophrenia made by DMS IV, hospitalized or followed
                  regularly in a hospital proper, and whose symptoms are stable for at least 6
                  weeks, at the discretion of the psychiatrist;

               4. Receiving antipsychotic treatment (risperidone or aripiprazole) monotherapy
                  stable (treatment and dose) for at least than 6 weeks;

               5. Showing no contra-indication for fMRI;

               6. Patients whose physical examination is unremarkable clinically significant;

               7. Patients without serious somatic pathology;

               8. Affiliated to a social security system.

               9. For women of childbearing potential, an appropriate contraception is mandatory
                  and an negative pregnancy test

          -  For controls

               1. Men and women, right handed, aged 18 to 45 years of age, sex and
                  socio-educational level comparable to patients included;

               2. Having given their written informed consent;

               3. Do not present a diagnosis of schizophrenia according to DSM IV set;

               4. Do not present psychiatric history, and free of any psychotropic medication;

               5. Including the physical examination is unremarkable clinically significant;

               6. Having no professional musical practice;

               7. Affiliated with a social security system.

        Exclusion Criteria:

          -  For patients

               1. Patients in menstruation without effective contraception (oral, intramuscular
                  hormonal, intrauterine device, or surgical);

               2. Patients who are pregnant or breastfeeding;

               3. Patients not meeting criteria for schizophrenia according to DSM IV criteria or
                  those with resistant schizophrenia (Kane criteria);

               4. Introducing a somatic disease or serious neurological, particularly Parkinson's
                  disease, epilepsy, tardive dyskinesia and disabling cardiovascular disease, liver
                  or kidney disease;

               5. Presenting a contra-indication to MRI;

               6. Having a history of alcoholism or drug addiction during the past year;

               7. Participating in another clinical trial or are in a period of exclusion from a
                  previous protocol;

               8. Patients likely to have behavioral self aggression from the trial investigators

                  During the study:

               1. The investigator considers, for safety reasons, it is in the interest of the
                  patient to be excluded from the study (Hospital readmission due to psychotic
                  symptoms, clinical or psychiatric reasons)

               2. Consentment withdrawal

               3. The patient does not longer correspond to the inclusion criteria or protocol
                  requirements

          -  For controls

               1. Women of childbearing potential without effective contraception (oral,
                  intramuscular hormonal, intrauterine device, or surgical);

               2. Pregnant or breastfeeding;

               3. Presenting a somatic, psychiatric or neurological disorder;

               4. Presenting a history of alcohol or substance abuse during the past year;

               5. Participating in another clinical trial or are in a period of exclusion from a
                  previous protocol;

               6. Presenting a contra-indication to MRI.