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NCT Number: NCT01109147

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Including the physical examination is unremarkable clinically significant;
  • Having no professional musical practice;
  • Affiliated with a social security system.

Exclusion criteria

  • 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;
  • Participating in another clinical trial or are in a period of exclusion from a previous protocol;
  • 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
  • The patient does not longer correspond to the inclusion criteria or protocol requirements
  • For controls
  • Women of childbearing potential without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical);
  • Pregnant or breastfeeding;
  • Presenting a somatic, psychiatric or neurological disorder;
  • Presenting a history of alcohol or substance abuse during the past year;
  • Participating in another clinical trial or are in a period of exclusion from a previous protocol;
  • Presenting a contra-indication to MRI.

Treatment and study plan

Imagery

Other

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

pharmacogenetic sampling

Genetic

A pharmacogenetic sample will be done with an additional consentment.

Primary outcomes

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

    Time frame: 3 days after the decision of inclusion

    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 outcomes

  1. Assessment of Emotional Reactivity

    Time frame: 3 days after the decision of inclusion

  2. Assessment of Cognitive and Attentional Abilities

    Time frame: 3 days after the decision of inclusion

  3. Assessment of Personality Traits

    Time frame: 3 days after the decision of inclusion

  4. Investigate the Level of Expression of Candidate Genes

    Time frame: one blood sample

Sponsors and collaborators

Lead sponsor

Qualissima

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 23, 2010
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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