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

NCT01109147 | Completed Phase 4 Results

• 1 other identifier: 2009-017673-38
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

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

Conditions

Schizophrenia, Undifferentiated Type

Keywords

Schizophrenic Disorders; Schizophrenia; Affect; Emotional Blunting

Outcome Measures

Primary Outcomes (1)

• Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI)

  During the fMRI session, the activation of each brain circuits is measured by a "Bold signal" (an arbitrary measure of contrast: numbers of voxels highlighted/activated in the region of interest). The emotional task is composed by congruent and incongruent images. Three effects were caused by the task: congruence, attention and valence effects. Each of them affect, involve and activate the regions of interests differentially within the differents arms. The region of interests who were mainly observed are: Anterior Cingulate Cortex (ACC), Prefrontal dorso-lateral Cortex (PFdlC) and the Amygdala (A).

  3 days after the decision of inclusion

Secondary Outcomes (4)

• Assessment of Emotional Reactivity

  3 days after the decision of inclusion

• Assessment of Cognitive and Attentional Abilities

  3 days after the decision of inclusion

• Assessment of Personality Traits

  3 days after the decision of inclusion

• Investigate the Level of Expression of Candidate Genes

  one blood sample

Study Arms (3)

aripiprazole

ACTIVE COMPARATOR

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.

Other: Imagery; Genetic: pharmacogenetic sampling

risperidone

ACTIVE COMPARATOR

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.

Other: Imagery; Genetic: pharmacogenetic sampling

control

OTHER

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

Other: Imagery; Genetic: pharmacogenetic sampling

Interventions

Imagery OTHER

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

aripiprazole; control; risperidone

pharmacogenetic sampling GENETIC

A pharmacogenetic sample will be done with an additional consentment.

aripiprazole; control; risperidone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For patients
• Men and women, right handed, 18 to 45 years;
• Having given their written informed consent;
• 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;
• Receiving antipsychotic treatment (risperidone or aripiprazole) monotherapy stable (treatment and dose) for at least than 6 weeks;
• Showing no contra-indication for fMRI;
• Patients whose physical examination is unremarkable clinically significant;
• Patients without serious somatic pathology;
• Affiliated to a social security system.
• For women of childbearing potential, an appropriate contraception is mandatory and an negative pregnancy test
• For controls
• Men and women, right handed, aged 18 to 45 years of age, sex and socio-educational level comparable to patients included;
• Having given their written informed consent;
• Do not present a diagnosis of schizophrenia according to DSM IV set;
• Do not present psychiatric history, and free of any psychotropic medication;

You may not qualify if:

• For patients
• Patients in menstruation without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical);
• Patients who are pregnant or breastfeeding;
• Patients not meeting criteria for schizophrenia according to DSM IV criteria or those with resistant schizophrenia (Kane criteria);
• Introducing a somatic disease or serious neurological, particularly Parkinson's disease, epilepsy, tardive dyskinesia and disabling cardiovascular disease, liver or kidney disease;
• Presenting a contra-indication to MRI;
• Having a history of alcoholism or drug addiction during the past year;
• Patients likely to have behavioral self aggression from the trial investigators
• During the study:
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• 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)
• Consentment withdrawal
• For controls
• Women of childbearing potential without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical);
• Pregnant or breastfeeding;

Sponsors & Collaborators

• Qualissima: lead

Study Sites (2)

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

Marseille, 13009, France

Location

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

Marseille, 13385, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Eric Fakra
• Organization: Hopital Sainte Marguerite - APHM - Service du Pr. Azorin

eric.fakra@ap-hm.fr

Study Officials

• Olivier Blin, professor

  study coordinator

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 23, 2010
• Study Start: December 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 9, 2014
• Results First Posted: April 9, 2014

Record last verified: 2014-03

Locations

FR (2)