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

NCT ID: NCT01109147

Last Updated: 2014-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-05-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

aripiprazole

Imagery: A fMRI session is conducted on schizophrenic patients under aripiprazole (medication taken and stabilized for at least six weeks before inclusion, no intervention on the medication is scheduled during the study).

Genetic: pharmacogenetic sampling. One sample was collected for each subject.

Group Type: ACTIVE_COMPARATOR

Imagery

Intervention Type: OTHER

All the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination.

pharmacogenetic sampling

Intervention Type: GENETIC

A pharmacogenetic sample will be done with an additional consentment.

risperidone

Imagery: A fMRI session is conducted on schizophrenic patients under rsiperidone (medication taken and stabilized for at least six weeks before inclusion, no intervention on the medication is scheduled during the study).

Genetic: pharmacogenetic sampling. One sample was collected for each subject.

Group Type: ACTIVE_COMPARATOR

Imagery

Intervention Type: OTHER

All the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination.

pharmacogenetic sampling

Intervention Type: GENETIC

A pharmacogenetic sample will be done with an additional consentment.

control

Imagery: A fMRI session is conducted on healthy volunteers. Genetic: pharmacogenetic sampling. One sample was collected for each subject.

Group Type: OTHER

Imagery

Intervention Type: OTHER

All the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination.

pharmacogenetic sampling

Intervention Type: GENETIC

A pharmacogenetic sample will be done with an additional consentment.

Interventions

Imagery

All the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination.

Intervention Type: OTHER

pharmacogenetic sampling

A pharmacogenetic sample will be done with an additional consentment.

Intervention Type: GENETIC

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.

• 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.

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:

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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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qualissima

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Blin, professor

Role: STUDY_DIRECTOR

study coordinator

Locations

Sainte-Marguerite Hospital - Psychiatric service -Service du Pr Azorin - 270 boulevard de Sainte Marguerite

Marseille, , France

Hôpital de la Conception - Service du Pr Dassa -147, boulevard Baille

Marseille, , France

Countries

France

Other Identifiers

2009-017673-38

Identifier Type: -

Identifier Source: org_study_id