Schizophrenia, Undifferentiated TypePhase 4NCT01109147

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

A Phase 4 study testing Imagery and pharmacogenetic sampling in people with Schizophrenia, Undifferentiated Type, run by Qualissima at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Schizophrenia, Undifferentiated Type
What is being tested?: Imagery and pharmacogenetic sampling
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 2 sitesFrance
Study dates: Dec 2010to May 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;

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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.

Who cannot join

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;

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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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

Sainte-Marguerite Hospital - Psychiatric service -Service du Pr Azorin - 270 boulevard de Sainte Marguerite
Marseille, 13009
Hôpital de la Conception - Service du Pr Dassa -147, boulevard Baille
Marseille, 13385

Other trials in France

About this study

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

Read the 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.

Conditions: Schizophrenia, Undifferentiated Type
Being tested: Imagery, pharmacogenetic sampling
Keywords: Schizophrenic Disorders, Schizophrenia, Affect, Emotional Blunting
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ImageryOther
All the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination.
pharmacogenetic samplingGenetic
A pharmacogenetic sample will be done with an additional consentment.

Study groups in NCT01109147
Study group	Role	What they receive
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. Receives: Other: Imagery; Genetic: pharmacogenetic sampling
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. Receives: Other: Imagery; Genetic: pharmacogenetic sampling
control	Other	Imagery: A fMRI session is conducted on healthy volunteers. Genetic: pharmacogenetic sampling. One sample was collected for each subject. Receives: Other: Imagery; Genetic: pharmacogenetic sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 3 days after the decision of inclusion

Secondary outcomes (4)

Assessment of Emotional Reactivity
Measured: 3 days after the decision of inclusion
Assessment of Cognitive and Attentional Abilities
Measured: 3 days after the decision of inclusion
Assessment of Personality Traits
Measured: 3 days after the decision of inclusion
Investigate the Level of Expression of Candidate Genes
Measured: one blood sample

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010May 2013

First posted23 Apr 2010 (estimated)
Study startDec 2010
Primary completionJan 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Schizophrenia, Undifferentiated TypeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01109147
Sponsor's protocol ID: 2009-017673-38
Other IDs: 2009
Status last verified: Mar 2014
First submitted: 21 Apr 2010
Last updated: 9 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01109147
Acronym / sponsor ID: 2009-017673-38
Conditions: Schizophrenia, Undifferentiated Type
Keywords: Schizophrenic Disorders, Schizophrenia, Affect, Emotional Blunting
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: QualissimaUniversity, hospital or other
Study start: Dec 2010
Primary completion: Jan 2013 (actual)
Study completion: May 2013 (actual)
First posted: 23 Apr 2010 (estimated)
Results: Posted 9 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
aripiprazole	Active comparator	Other: Imagery, Genetic: pharmacogenetic samplingImagery: 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	Other: Imagery, Genetic: pharmacogenetic samplingImagery: 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	Other: Imagery, Genetic: pharmacogenetic samplingImagery: A fMRI session is conducted on healthy volunteers. Genetic: pharmacogenetic sampling. One sample was collected for each subject.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (18 listed)

For patients
For controls

Key exclusion criteria (21 listed)

For patients
For controls

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ImageryAll the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination.	Other	aripiprazole, control, risperidone
pharmacogenetic samplingA pharmacogenetic sample will be done with an additional consentment.	Genetic	aripiprazole, control, risperidone

Primary outcome

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).

4 secondary outcomes

Assessment of Emotional Reactivity
Time frame: 3 days after the decision of inclusion
Assessment of Cognitive and Attentional Abilities
Time frame: 3 days after the decision of inclusion
Assessment of Personality Traits
Time frame: 3 days after the decision of inclusion
Investigate the Level of Expression of Candidate Genes
Time frame: one blood sample

Results and safety

Results posted to the registry on 9 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole	17	15
Risperidone	14	11
Control	36	26

Primary outcome: Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI)

Time frame: 3 days after the decision of inclusion. Mean (Standard Error). Unit: arbitrary units of activation

Measure	Aripiprazole n = 15	Risperidone n = 11	Control n = 26
Activation of Anterior Cingulate Cortex (ACC)	-0.25 (2.8)	-0.21 (3.1)	3.8 (3.2)
Activation of Prefrontal dorso-lateral Cortex (PF)	0.2 (3.0)	-0.3 (4.0)	5.3 (5.0)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Assessment of adverse event at each visit (2 times on approximately one week).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole	0 of 17 (0%)	0 of 17 (0%)	Not reported
Risperidone	0 of 14 (0%)	0 of 14 (0%)	Not reported
Control	0 of 36 (0%)	1 of 36 (2.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Olivier Blin, professor study director

study coordinator

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Imagery and pharmacogenetic sampling in people with Schizophrenia, Undifferentiated Type, run by Qualissima at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI) (time frame: 3 days after the decision of inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01109147.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.