Trial Outcomes & Findings for Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients (NCT NCT01109147)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

67 participants

Primary outcome timeframe

3 days after the decision of inclusion

Results posted on

2014-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Aripiprazole Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion	Risperidone Schizophrenic patient stabilized under risperidone for six weeks before inclusion	Control healthy volunteers
Overall Study STARTED	17	14	36
Overall Study COMPLETED	15	11	26
Overall Study NOT COMPLETED	2	3	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole n=17 Participants Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion	Risperidone n=14 Participants Schizophrenic patient stabilized under risperidone for six weeks before inclusion	Control n=36 Participants healthy volunteers	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	14 Participants n=7 Participants	36 Participants n=5 Participants	67 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	34.6 years STANDARD_DEVIATION 9.6 • n=5 Participants	31.6 years STANDARD_DEVIATION 9.2 • n=7 Participants	32.9 years STANDARD_DEVIATION 7.8 • n=5 Participants	33.1 years STANDARD_DEVIATION 8.5 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants	43 Participants n=4 Participants
Region of Enrollment France	17 participants n=5 Participants	14 participants n=7 Participants	36 participants n=5 Participants	67 participants n=4 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Aripiprazole n=15 Participants Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion	Risperidone n=11 Participants Schizophrenic patient stabilized under risperidone for six weeks before inclusion	Control n=26 Participants healthy volunteers
Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI) Activation of Anterior Cingulate Cortex (ACC)	-0.25 arbitrary units of activation Standard Error 2.8	-0.21 arbitrary units of activation Standard Error 3.1	3.8 arbitrary units of activation Standard Error 3.2
Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI) Activation of Prefrontal dorso-lateral Cortex (PF)	0.2 arbitrary units of activation Standard Error 3.0	-0.3 arbitrary units of activation Standard Error 4.0	5.3 arbitrary units of activation Standard Error 5.0

SECONDARY outcome

Timeframe: 3 days after the decision of inclusion

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 days after the decision of inclusion

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 days after the decision of inclusion

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one blood sample

Outcome measures

Outcome data not reported

Adverse Events

Aripiprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Risperidone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Aripiprazole n=17 participants at risk Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion	Risperidone n=14 participants at risk Schizophrenic patient stabilized under risperidone for six weeks before inclusion	Control n=36 participants at risk healthy volunteers
Nervous system disorders Presyncope	0.00% 0/17 • 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).	0.00% 0/14 • 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).	2.8% 1/36 • Number of events 1 • 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).

Additional Information

Dr. Eric Fakra

Hopital Sainte Marguerite - APHM - Service du Pr. Azorin

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All results and publications are reviewed by the sponsor and the principle Investigator. None could be released without accordance from both parts.
Publication restrictions are in place

Restriction type: OTHER