Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| control | Other | Imagery: A fMRI session is conducted on healthy volunteers. Genetic: pharmacogenetic sampling. One sample was collected for each subject. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imagery | Other | All the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Emotional Reactivity | 3 days after the decision of inclusion | |
| Assessment of Cognitive and Attentional Abilities | 3 days after the decision of inclusion | |
Not provided
Inclusion Criteria:
For patients
For controls
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:
For controls
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olivier Blin, professor | study coordinator | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sainte-Marguerite Hospital - Psychiatric service -Service du Pr Azorin - 270 boulevard de Sainte Marguerite | Marseille | 13009 | France | |||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion |
| FG001 | Risperidone | Schizophrenic patient stabilized under risperidone for six weeks before inclusion |
| FG002 | Control | healthy volunteers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants was calculated as an estimation, due to no previous known results in this field of research.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion |
| BG001 | Risperidone | Schizophrenic patient stabilized under risperidone for six weeks before inclusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Assessment of Emotional Reactivity | Not Posted | 3 days after the decision of inclusion | |||||||||||||
| Secondary | Assessment of Cognitive and Attentional Abilities | Not Posted | 3 days after the decision of inclusion |
Assessment of adverse event at each visit (2 times on approximately one week).
Assessment of adverse event has been run by the investiagtor at each visit (2 times) during the entire participation of the subject (approximately one week).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole | Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Presyncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment | after a blood puncture |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Fakra | Hopital Sainte Marguerite - APHM - Service du Pr. Azorin | eric.fakra@ap-hm.fr |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| pharmacogenetic sampling | Genetic | A pharmacogenetic sample will be done with an additional consentment. |
|
| Assessment of Personality Traits |
| 3 days after the decision of inclusion |
| Investigate the Level of Expression of Candidate Genes | one blood sample |
| Hôpital de la Conception - Service du Pr Dassa -147, boulevard Baille |
| Marseille |
| 13385 |
| France |
| BG002 | Control | healthy volunteers |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Assessment of Personality Traits | Not Posted | 3 days after the decision of inclusion |
| Secondary | Investigate the Level of Expression of Candidate Genes | Not Posted | one blood sample |
| Primary | 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). | Posted | Mean | Standard Error | arbitrary units of activation | 3 days after the decision of inclusion |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Risperidone | Schizophrenic patient stabilized under risperidone for six weeks before inclusion | 0 | 14 | 0 | 14 |
| EG002 | Control | healthy volunteers | 0 | 36 | 1 | 36 |
|
All results and publications are reviewed by the sponsor and the principle Investigator. None could be released without accordance from both parts.
|