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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01109147
• Date of registration: 21/04/2010
• Prospective Registration: Yes
• Primary sponsor: Qualissima
• Public title: Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients
• Scientific 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
• Date of first enrolment: December 2010
• Target sample size: 67
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01109147
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Olivier Blin, professor
• Affiliation: study coordinator

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia, Undifferentiated Type

Intervention(s)

Genetic: pharmacogenetic sampling

Other: Imagery

Primary Outcome(s)

Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI) [Time Frame: 3 days after the decision of inclusion]

Secondary Outcome(s)

Assessment of Cognitive and Attentional Abilities [Time Frame: 3 days after the decision of inclusion]

Assessment of Emotional Reactivity [Time Frame: 3 days after the decision of inclusion]

Investigate the Level of Expression of Candidate Genes [Time Frame: one blood sample]

Assessment of Personality Traits [Time Frame: 3 days after the decision of inclusion]

Secondary ID(s)

2009-017673-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/04/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01109147