An observational study in Bipolar Disorders, sponsored by AstraZeneca. Completed at 46 sites in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-12-22.
Sponsored by AstraZeneca · Observational
The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and clinical evaluation will be recorded and potential differences that may exist due to epidemiological factors or comorbidities will be analyzed.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's planned enrollment of 152 is close to the median of 160 across 329 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Outpatients (male or female), diagnosed with Bipolar I or II disorder, having presented or presenting a major depressive episode (according to DSM-IV-TR) with starting date of 6 months maximum before the inclusion.
Exclusion Criteria:
Details of any AAP prescribed 1 to 6 months prior to the first study visit:
Time frame: 4 visits
Montgomery Asberg Depression Rating Scale (MADRS), a 10-point observer rating scale, used to assess the symptoms and severity of depression.
Time frame: 4 visits
Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania.
Time frame: 4 visits
Remission rate for the major depressive episode, in progress at inclusion
Time frame: At completion
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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