Bipolar Disorder
Conditions
Keywords
Acute mania, Bipolar disorder, depressive symptoms, mixed mania
Brief summary
Observational, non-interventional, transversal, multicenter, open label (No treatment is involved). The primary objective is to detect the prevalence of depressive symptoms in bipolar patients admitted to a psychiatric Unit due to an acute mania episode. Secondary objectives include 1) to evaluate, the relationship between depressive symptoms and severity of mania; 2) to evaluate, the relationship between depressive symptoms and anxiety; 3) to evaluate, the relationship between depressive symptoms and psychotic symptoms; 4) to evaluate, the relationship between depressive symptoms and insight; 5) to evaluate, the relationship between depressive symptoms and clinical global impression; 6) to evaluate, the relationship between depressive symptoms and previous treatment with antipsychotics (whatever the antipsychotic was); 7) to evaluate, the relationship between depressive symptoms and length of admission; 8) to evaluate factors (demographic, evolution…) which could be involved in the presence of depressive symptoms within an acute manic episode; 9) to evaluate, the difference on the initial prescription due to the detection of depressive symptoms; 10) to evaluate, if exists, differences on the previous psychiatric diagnosis in patients with and without depressive symptoms. The primary endpoint is score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed of Bipolar Disorder based on DSM-IV-TR * Patients admitted to an acute inpatient psychiatric Unit due to an acute manic episode (as defined in DSM-IV\_TR) * Provision of written informed consent. * Total score in Young Mania Rating Scale \>=20 * Able to understand and comply with the requirements of the study
Exclusion criteria
* Mental retardation * Patients with manic symptoms are due to substance use, based in the investigator opinion * Patients with unstable organic diseases, who are not receiving adequate treatment, according the investigator opinion. * Participation in a trial with drugs within 4 weeks of enrolment into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania. | once during study |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (5 items) | once during study |
| Scale of Unawareness of Mental Disorders (SUMD) | once during study |
| Mania symptoms measured with YMRS (Young Mania Rating Scale). | once during study |
| Days of hospitalization, MADRS (6 items) | once during study |
| Psychotic symptoms measured with BPRS (Brief Psychosis Rating Scale). | once during study |
| Clinical status and improvement measured with CGI-BP (Clinical Global Impression - Bipolar scale). | once during study |
| Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale). | once during study |
Countries
Spain
Outcome results
None listed