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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Qualissima
ClinicalTrials.gov Identifier:
NCT01109147
First received: April 21, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Schizophrenia, Undifferentiated Type
Other: Imagery
Genetic: pharmacogenetic sampling
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Qualissima:

Primary Outcome Measures:
  • Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI) [ Time Frame: 3 days after the decision of inclusion ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Assessment of Emotional Reactivity [ Time Frame: 3 days after the decision of inclusion ] [ Designated as safety issue: No ]
  • Assessment of Cognitive and Attentional Abilities [ Time Frame: 3 days after the decision of inclusion ] [ Designated as safety issue: No ]
  • Assessment of Personality Traits [ Time Frame: 3 days after the decision of inclusion ] [ Designated as safety issue: No ]
  • Investigate the Level of Expression of Candidate Genes [ Time Frame: one blood sample ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: December 2010
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.

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.
Active Comparator: 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.

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109147

Locations
France
Sainte-Marguerite Hospital - Psychiatric service -Service du Pr Azorin - 270 boulevard de Sainte Marguerite
Marseille, France, 13009
Hôpital de la Conception - Service du Pr Dassa -147, boulevard Baille
Marseille cedex 5, France, 13385
Sponsors and Collaborators
Qualissima
Investigators
Study Director: Olivier Blin, professor study coordinator
  More Information

No publications provided

Responsible Party: Qualissima
ClinicalTrials.gov Identifier: NCT01109147     History of Changes
Other Study ID Numbers: 2009-017673-38
Study First Received: April 21, 2010
Results First Received: August 29, 2013
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Qualissima:
Schizophrenic Disorders
Schizophrenia
Affect
Emotional Blunting

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Aripiprazole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 17, 2014