The overarching objective of the study is to investigate whether individuals with schizophrenia, individuals with depression and healthy controls, on a group level, differ in performance on three previously-validated experimental computer tasks. All…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will use one main outcome measure per task as a formal primary endpoint. As
a primary study endpoint for the Grip Strength task we will compare the
percentage of hard task choices at different reward levels in the Grip Strength
Task, which will be compared at a group level between MDD vs. matched healthy
controls, SZ vs. matched healthy controls, and MDD vs SZ. For the Reinforcement
Learning/Working Memory task, we will compare the number of optimal choices per
set size condition (2-5) between these groups, and for the Doors task,
percentage of trials on which a participant choose the other door after
experiencing a loss (*lose-shifting*). The test-retest reliability of these
outcome measures will be investigated.
Secondary outcome
- We will compare group-level (control, MDD, SZ) means and distributions
(standard deviations) of our primary endpoints with previously published work.
- Per task, we will compare event-related potential (ERPs, obtained from the
EEG data) between the three groups
- Relationships between primary task endpoints, EEG endpoints and symptom
severity (SHAPS sum scores) will be investigated using correlational analyses
- the intraclass correlation coefficient for all outcome measures mentioned
under point 1 and 2 will be investigated.
Background summary
Rationale: Deficits or abnormalities in reward processing are present in a
number of psychiatric disorders. Reward processing deficits in depression are
thought to be linked to the presence of anhedonia (reduced ability to
experience pleasure), while in schizophrenia to negative symptoms more
generally. This study will investigate group differences in reward processing
and learning between individuals with schizophrenia, depression, and healthy
controls.
Study objective
The overarching objective of the study is to investigate whether individuals
with schizophrenia, individuals with depression and healthy controls, on a
group level, differ in performance on three previously-validated experimental
computer tasks. All tasks measures aspects of reward learning and/or
processing. We will also investigate how the severity of negative symptoms
correlates with task performance. We will also investigate the test-retest
reliability of our outcome measures.
Study design
Study design: MDD and SZ participants, as well as healthy control volunteers
matched to the patient groups, will attend at least one study visit, comprising
inclusion/exclusion screening, questionnaires and clinical assessment, and
completion of three reward processing tasks, two of which are administered with
simultaneous collection of EEG data. A subsample will complete the same study
visit a second time, with the aim of assessing the test-retest reliability of
the outcome measures.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: As a non-interventional study in which all
participants complete a single study visit of maximum 5.5 hours, with
non-invasive EEG measurements, risks are negligible and participant burden is
minimal. A subsample of participants will undergo the same session a second
time (for test-retest purposes). For some of the instruments the test-retest
reliability has never been assessed. Recruitment of patient groups (MDD and SZ)
is necessary for this study because we wish to specifically improve
understanding of group differences between these two clinical groups.
Vijverdalseweg 1
Maastricht 6226NB
NL
Vijverdalseweg 1
Maastricht 6226NB
NL
Listed location countries
Age
Inclusion criteria
All groups:
- male/female
- age 20-55
- be able to read, write, and speak the language in which psychometric tests
are provided
Schizophrenia group
- Primary diagnosis of schizophrenia (according to DSM-V)
Depression group
- Primary diagnosis of major depressive disorder (according to DSM-V)
Exclusion criteria
All groups:
- history of substance abuse (DSM-V)
- history of neurological disorder (Parkinson's, epilepsy, Alzheimer's)
- diagnosis of mental retardationTwo patient groups:
- Bipolar disorder (DSM-V)
- Obsessive-Compulsive disorder (DSM-V)
- Eating disorder (DSM-V)
- Attention-deficit hyperactivity disorder (DSM-V)
- Received treatment with clozapine in the last 6 months before screening.
- Experienced an acute exacerbation requiring hospitalization within the last 3
months.
- major changes to medication (~30% dose change) in the 4 weeks prior to
participation
Design
Recruitment
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 |
|---|---|
| CCMO | NL69565.068.19 |