This study looks if the third generation antipsychotic aripiprazole can improve activity of the prefrontal cortex and cognitive and social function, when compared to the second generation antipsychotic risperidone.
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in brain activity of the prefrontal cortex between groups with
different medication. Besides accuraty and reactiontimes during task
performance and severeness of positive and negative symptoms.
Secondary outcome
nvt
Background summary
Schizophrenia is characterized by a widespread cognitive disfunction, affecting
the domains of memory, learning, attention and executive functioning. Besides,
disabilities in social functioning excist, one of the main characteristics of
schizophrenia. These problems are possibly caused by disminished activity of
the prefrontal cortex. The third generation antipsychotic Abilify
(aripipralole) can restore improve the activity of the prefrontal cortrex. This
could cause a decrease in negative symptoms and improve social cognition.
Risperdal (risperidone) has another mode of action, in which dopamine is
blocked in the whole brain. Therefore the expectations are that activity of the
prefrontal cortex will not increase substantially when Risperdal is prescribed,
in contrast to Abilify that will activate the prefrontal cortex.
Study objective
This study looks if the third generation antipsychotic aripiprazole can improve
activity of the prefrontal cortex and cognitive and social function, when
compared to the second generation antipsychotic risperidone.
Study design
24 patients suffering from schizophrenia will be randomly assigned to Abilify
(aripiprazole) or Risperdal (risperidone), only when no clear preference
excists for one of the two kinds of medication. During the treatment there will
be regular visits to the clinician in charge. Before onset of medication intake
an MRI experiment will be conducted. Subsequentially a transitionperiod of
three weeks to Abilify or Risperdal takes place. In this period the current
medication is gradually decreased while the intake of the new medicines is
gradually increased. Next treatment with new medication will be continued for
four weeks. After this period a second MRI experiment will take place.
The fMRI experiments are composed of different tasks which activate the
prefrontal cortex. Activity of the prefrontal cortex will be compared between
patient groups, before and after use of Abilify and Risperdal. Activity of the
prefontal cortex and social cognition should inprove (more) after treatment
with aripiprazole. Besides positive and negative symptoms of schizophrenia will
the rated with a structured interview, the PANSS.
Besides, 20 healthy controls will be included. They will be subjected to one
MRI-session, and no antipsychotics will be administered. On a seperate
occassion they will be interviewed with the mini-SCAN. This is a short,
diagnostic interview to exclude psychiatric illnessess.
Study burden and risks
The study consists of two MRI experiments with a scantime of 75 minutes, a
structured interview (PANSS, 30 minutes) and two questionares. Comparibles
studies have been carried out before and were experienced as only being a
slight effort for subjects.
The medication that is used is prescribed by a clinician only if this is
medically relevant. In case of side effects or increase of symptoms the study
will be terminated.
Antonius Deusinglaan 2
9713 AW Groningen
NL
Antonius Deusinglaan 2
9713 AW Groningen
NL
Listed location countries
Age
Inclusion criteria
People diagnozed for schizophrenia according to DSM-IV. They should not repsond to first choiche treatment or suffer from serious side effects.
Besides, healthy control without high education level.
Exclusion criteria
Subjects with a psychiatric or neurologic disease other than schizophrenia, for which they have been treated. Presence of MRI incompatible implants. For safety reasons female participants who may be pregnant will be excluded.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-002748-79-NL |
| CCMO | NL17987.042.07 |