Depressive Symptoms in Acute Manic Episode

Study Overview
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Brief Summary
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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

Official Title
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Prevalence of Depressive Symptoms in Manic Episodes of Bipolar Patients: an Observational Study

Conditions
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Bipolar Disorder

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Bipolar patients admitted to a psychiatric Unit due to an acute mania episode. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania. |  | once during study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mania symptoms measured with YMRS (Young Mania Rating Scale). |  | once during study | 
| Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale). |  | 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 | 
| Days of hospitalization, MADRS (6 items) |  | once during study | 
| Hamilton Depression Rating Scale (5 items) |  | once during study | 
| Scale of Unawareness of Mental Disorders (SUMD) |  | once during study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute mania, Bipolar disorder, depressive symptoms, mixed mania