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 diagnosios tool for…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will compare performance on the exogenous curing task between MDD, BD and
HC, measured by response time, number of omissions and number of errors. The
same outcome 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 prefontal cortex (PFC) ventral PFC, orbitofrontal, limbic and
subcortical regions).
Secondary outcome
not applicable
Background summary
The study concerns the diagnosis of major depressive disorder (MDD) and bipolar
disorder (BD). Early differentation between both disorders is very important,
since treatments differ, and providing the wrong therapy is associated with
prolonged illness duration and recurrence. However the diagnosis is often
unclear due to the fact that ; (1) clinical characteristics of a major
depressive episode (MDE) in both diosorders is not clearly discriminate, (2)
retrospective assesments of a (hypo)manic episodeis usually equivocal and (3)
(hypo)manic episodes may occur long after the first MDE. Current diagnostic
tools (i.e. questionaires and interviews) are rather insensitive, rendering a
diagnostic grey zone of false negative diagnosis for BD. Therefor additional
diagnostic procedures are required. At best, this could be procedures to
indentify disease specific brain-processes (biomarkers). Since findings from
recent affective neuropychological and fMRI sutdies 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 unmedicate 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
diagnosios 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
Study burden and risks
There is no immediatly 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 major health risk.
Meibergdreef 5
1105 AZ Amsterdam
NL
Meibergdreef 5
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
All MDD and BD I and BD II patients of both sexes: age 18-60 years; at least 2 MDEs, with remission between episodes; age of first episode * 40 years; illness duration of * 5 years since the first episode.
Non-depressed MDD and BD patients: no diagnosis of major depressieve episode (MDE) at time of baseline (according to SCID)
In addition, for BD: at least one manic episode (assessed by SCID) not solely during the use of antidepressants.
Healthy controls: age 18-60 years; euthymia at time of baseline (According to SCID; Inventory for Depressive Symptoms (IDS) *14)
Exclusion criteria
MDD and BD I / II patients: electroconvulsive therapy within 2 months before scanning; current (hypo)mania (Young Mania Rating Scale (YMRS) > 8; at study entry or within the previous month before baseline); a current depressive episode according to the SCID or a HDRS>16; 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 parasuicidal acts); currently using psychopharmacological medication (antidepressants, anticonvulsants or mood-stabilizers stopped *1 month 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
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL36226.018.11 |