Phase 4
Completed N=67
Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients
Schizophrenia, Undifferentiated Type
Source: ClinicalTrials.gov NCT01109147 ↗
Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI) — -0.25; -0.21; 3.8; 0.2 arbitrary units of activation
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI) |
-0.25; -0.21; 3.8; 0.2; -0.3; 5.3 | — |
| SECONDARY Assessment of Emotional Reactivity |
— | — |
| SECONDARY Assessment of Cognitive and Attentional Abilities |
— | — |
| SECONDARY Assessment of Personality Traits |
— | — |
| SECONDARY Investigate the Level of Expression of Candidate Genes |
— | — |
Eligibility Criteria
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT01109147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.