We aim to (1) improve differential diagnosis of recurrent MDD and BD by investigating biomarkers at a neuropsychological and neurobiological level; (2) investigate whether affective neuropsychological testing can be used as a diagnostic tool for MDD…
ID
Source
Brief title
Condition
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will compare performance on the affective go/no-go task between MDD, BD I
and HC, measured by response time, number of omissions and number of errors.
The same outcomes will be examined for the neuroimaging tasks. We will compare
brain responses of fMRI tasks relative to control conditions between MDD, BD
and HC. We will compare responses in predefined ventral and dorsal brain
regions (dorsolateral prefrontal cortex (PFC), ventral PFC, orbitofrontal,
limbic and subcortical regions).
Secondary outcome
Not applicable
Background summary
This study concerns the diagnosis of major depressive disorder (MDD) and
bipolar disorder (BD). Early differentiation between both disorders is very
important, since treatments differ, and providing the wrong therapy is
associated with prolonged illness duration and recurrence. However, when a
patient presents with a major depressive episode (MDE), diagnosis is often
unclear due to the fact that (1) clinical characteristics of MDE in both
disorders do not clearly discriminate, (2) retrospective assessment of a
(hypo)manic episode is usually equivocal and (3) (hypo)manic episodes may
occur long after the first MDE. Current diagnostic tools (i.e., questionnaires
and interviews) are rather insensitive, rendering a diagnostic grey zone of
false negatives diagnosis for BD. Therefore additional diagnostic procedures
are required. At best, this could be procedures to identify disease specific
brain-processes (biomarkers). Since findings from recent affective
neuropsychological and fMRI studies indicate differences in emotional
processing between MDD and BD, these instruments are promising candidates for
detecting such biomarkers. Until now, only two studies directly compared MDD
and depressed BD with healthy controls (HC). Furthermore, in most studies,
medication use was allowed, which may have been an important confounder. To
investigate the value of neuropsychological testing and/or fMRI for diagnosis,
new studies and replications of earlier research of these biomarkers are
needed, preferably in direct comparisons of unmedicated MDD and BD patients
versus HC.
Study objective
We aim to (1) improve differential diagnosis of recurrent MDD and BD by
investigating biomarkers at a neuropsychological and neurobiological level; (2)
investigate whether affective neuropsychological testing can be used as a
diagnostic tool for MDD and BD; and (3) investigate whether fMRI can be used
for this purpose.
Study design
The study is a cross sectional study with prospective follow up for a period of
2.5 years in an outpatient population.
Study burden and risks
There is no immediate advantage for the participants. All depressed patients
will be offered treatment according to treatment guidelines. On the other hand,
the study is neither very burdensome, nor does it carry a major health risk.
Meibergdreef 5
1105 AZ Amsterdam
NL
Meibergdreef 5
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Major depressive disorder (MDD) and Bipolar disorder I (BD I) patients of both sexes: age 20-60 years; various levels of depressive symptomatology, ranging from moderate (HDRS * 16), to severe; at least 2 major depressive episodes, with remission between episodes; age of first episode * 30 years; illness duration of * 5 years since the first episode.
In addition, for BD I: at least one manic episode (assessed by SCID) not solely during the use of antidepressants.
Healthy controls (HC): age 20-60 years; euthymia at time of baseline (IDS * 14)
Exclusion criteria
MDD and BD I patients: electroconvulsive therapy within 2 months before scanning; current (hypo)mania (Young Mania Rating Scale (YMRS) > 8; at study entry or within the previous 4 months before baseline); atypical depressive symptomatology; concurrent co-morbid Axis I diagnosis; a clear clinical diagnosis of cluster B personality disorder (assessed by previous documentation and/or a history of recurrent suicidal and/or parasuicidal acts); currently using psychopharmacological medication (antidepressants, anticonvulsants or mood-stabilizers stopped * 2 months before scanning). Incidental benzodiazepine use will be allowed, but must be stopped before scanning.
In addition, for MDD: a history of (hypo)manic derailment after antidepressant use; a family history of bipolar disorder.
HC: a lifetime psychiatric diagnosis (axis I, assessed by SCID); a current diagnosis of alcohol or drug dependence; first-degree relatives with a history of a psychiatric diagnosis; use of any psychopharmacological agent.
All subjects: a history of head trauma or neurological disease; severe general physical illness; claustrophobia or implanted metal objects.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL24252.018.08 |
| OMON | NL-OMON20999 |