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

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ClinicalTrials.gov Identifier: NCT01109147
Recruitment Status : Completed
First Posted : April 23, 2010
Results First Posted : April 9, 2014
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
Qualissima

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Schizophrenia, Undifferentiated Type
Interventions Other: Imagery
Genetic: pharmacogenetic sampling
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole Risperidone Control
Hide Arm/Group Description Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion Schizophrenic patient stabilized under risperidone for six weeks before inclusion healthy volunteers
Period Title: Overall Study
Started 17 14 36
Completed 15 [1] 11 [2] 26 [3]
Not Completed 2 3 10
[1]
2 have been excluded of the results
[2]
3 have been excluded of the results
[3]
10 have been excluded of the results
Arm/Group Title Aripiprazole Risperidone Control Total
Hide Arm/Group Description Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion Schizophrenic patient stabilized under risperidone for six weeks before inclusion healthy volunteers Total of all reporting groups
Overall Number of Baseline Participants 17 14 36 67
Hide Baseline Analysis Population Description
The number of participants was calculated as an estimation, due to no previous known results in this field of research.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 36 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
14
 100.0%
36
 100.0%
67
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 14 participants 36 participants 67 participants
34.6  (9.6) 31.6  (9.2) 32.9  (7.8) 33.1  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 36 participants 67 participants
Female
8
  47.1%
4
  28.6%
12
  33.3%
24
  35.8%
Male
9
  52.9%
10
  71.4%
24
  66.7%
43
  64.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 17 participants 14 participants 36 participants 67 participants
17 14 36 67
1.Primary Outcome
Title Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI)
Hide Description

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).

Time Frame 3 days after the decision of inclusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aripiprazole Risperidone Control
Hide Arm/Group Description:
Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
Schizophrenic patient stabilized under risperidone for six weeks before inclusion
healthy volunteers
Overall Number of Participants Analyzed 15 11 26
Mean (Standard Error)
Unit of Measure: arbitrary units of activation
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)
2.Secondary Outcome
Title Assessment of Emotional Reactivity
Hide Description [Not Specified]
Time Frame 3 days after the decision of inclusion
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Assessment of Cognitive and Attentional Abilities
Hide Description [Not Specified]
Time Frame 3 days after the decision of inclusion
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Assessment of Personality Traits
Hide Description [Not Specified]
Time Frame 3 days after the decision of inclusion
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Investigate the Level of Expression of Candidate Genes
Hide Description [Not Specified]
Time Frame one blood sample
Outcome Measure Data Not Reported
Time Frame Assessment of adverse event at each visit (2 times on approximately one week).
Adverse Event Reporting Description 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).
 
Arm/Group Title Aripiprazole Risperidone Control
Hide Arm/Group Description Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion Schizophrenic patient stabilized under risperidone for six weeks before inclusion healthy volunteers
All-Cause Mortality
Aripiprazole Risperidone Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole Risperidone Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/14 (0.00%)      0/36 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aripiprazole Risperidone Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/14 (0.00%)      1/36 (2.78%)    
Nervous system disorders       
Presyncope  1 [1]  0/17 (0.00%)  0 0/14 (0.00%)  0 1/36 (2.78%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
[1]
after a blood puncture
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All results and publications are reviewed by the sponsor and the principle Investigator. None could be released without accordance from both parts.
Results Point of Contact
Name/Title: Dr. Eric Fakra
Organization: Hopital Sainte Marguerite - APHM - Service du Pr. Azorin
Responsible Party: Qualissima
ClinicalTrials.gov Identifier: NCT01109147     History of Changes
Other Study ID Numbers: 2009-017673-38
First Submitted: April 21, 2010
First Posted: April 23, 2010
Results First Submitted: August 29, 2013
Results First Posted: April 9, 2014
Last Update Posted: April 9, 2014