Clinical trial NCT00690248: Depressive Symptoms in Acute Manic Episode
Official title: Prevalence of Depressive Symptoms in Manic Episodes of Bipolar Patients: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Acute mania
Bipolar disorder
depressive symptoms
mixed mania
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: bipolar patients admitted to a psychiatric Unit due to an acute mania episode.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania.
timeFrame: once during study
Secondary outcomes:
measure: Mania symptoms measured with YMRS (Young Mania Rating Scale).
timeFrame: once during study
measure: Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale).
timeFrame: once during study
measure: Psychotic symptoms measured with BPRS (Brief Psychosis Rating Scale).
timeFrame: once during study
measure: Clinical status and improvement measured with CGI-BP (Clinical Global Impression - Bipolar scale).
timeFrame: once during study
measure: Days of hospitalization, MADRS (6 items)
timeFrame: once during study
measure: Hamilton Depression Rating Scale (5 items)
timeFrame: once during study
measure: Scale of Unawareness of Mental Disorders (SUMD)
timeFrame: once during study
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Research Site
city: Algeciras
country: Spain
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: La Coruna
country: Spain
facility: Research Site
city: Las Palmas
country: Spain
facility: Research Site
city: Logrono
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Osuna
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Plasencia
country: Spain
facility: Research Site
city: Ponferrada
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: San Juan (Alicante)
country: Spain
facility: Research Site
city: Sant Boi de Llobregat
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Tenerife
country: Spain
facility: Research Site
city: Teruel
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Vitoria
country: Spain
facility: Research Site
city: Zamora
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
References: