to assess whether a single-dose of levodopa improves cognitive symptoms and balances goal-directed and habitual behavior.
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
cognitive functioning as assessed by a habit formation task and a n-back
working memory task
Secondary outcome
clinical variables as measured by a panss interview and two questionnaires
Background summary
Schizophrenia encompasses positive, negative and cognitive symptoms. While
antipsychotic medication generally alleviates the positive symptoms, negative
and cognitive symptoms remain unchanged. And this while the latter seem to be
the best predictors for long-term outcome.
Study objective
to assess whether a single-dose of levodopa improves cognitive symptoms and
balances goal-directed and habitual behavior.
Study design
double-blind, randomized, placebo-controlled study with a single dose of
levodopa in schizophrenic patients
Intervention
Admission of a single dose of Sinemet
Study burden and risks
Overall burden is low. A small risk exists for increasing the positive
symptoms. To minimize this risk, the study will be conducted entirely at the
psychiatric ward where the patients are admitted, so that they are under
constant supervision.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
All patients will be recruited from the Psychiatry ward of the Erasmus Medical Center, Rotterdam, and diagnosed according to DSM-IV criteria by a senior psychiatrist Patients will be included if they meet the criteria for schizophrenia. Further inclusion criteria inpatients aged 18-35 years with a diagnosis of schizophrenia, stable on antipsychotic, with illness duration < 5 years
Exclusion criteria
pregnancy, use of psychotropic medication other than benzodiazepines, serious neurological disorders. Subjects will also be excluded when they cannot understand Dutch language sufficiently to understand the purposes and implications of the experiment.
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 | EUCTR2012-002187-27-NL |
| CCMO | NL40710.078.12 |