Diagnostic Imaging of Affective Disorders using Emotion-processing (DIADE) A neuroimaging study to determine biomarkers to discriminate unipolar and bipolar depressio
- Conditions
- bipolar disorderdepressionmood disorders
- Registration Number
- NL-OMON32689
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
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)
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>We will compare performance on the affective go/no-go task between MDD, BD I<br /><br>and HC, measured by response time, number of omissions and number of errors.<br /><br>The same outcomes will be examined for the neuroimaging tasks. We will compare<br /><br>brain responses of fMRI tasks relative to control conditions between MDD, BD<br /><br>and HC. We will compare responses in predefined ventral and dorsal brain<br /><br>regions (dorsolateral prefrontal cortex (PFC), ventral PFC, orbitofrontal,<br /><br>limbic and subcortical regions). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>