Depressive Symptoms in Acute Manic Episode (MM1)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690248
First received: June 2, 2008
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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


Condition
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Prevalence of Depressive Symptoms in Manic Episodes of Bipolar Patients: an Observational Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania. [ Time Frame: once during study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mania symptoms measured with YMRS (Young Mania Rating Scale). [ Time Frame: once during study ] [ Designated as safety issue: No ]
  • Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale). [ Time Frame: once during study ] [ Designated as safety issue: No ]
  • Psychotic symptoms measured with BPRS (Brief Psychosis Rating Scale). [ Time Frame: once during study ] [ Designated as safety issue: No ]
  • Clinical status and improvement measured with CGI-BP (Clinical Global Impression - Bipolar scale). [ Time Frame: once during study ] [ Designated as safety issue: No ]
  • Days of hospitalization, MADRS (6 items) [ Time Frame: once during study ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale (5 items) [ Time Frame: once during study ] [ Designated as safety issue: No ]
  • Scale of Unawareness of Mental Disorders (SUMD) [ Time Frame: once during study ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Bipolar patients admitted to a psychiatric Unit due to an acute mania episode.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

bipolar patients admitted to a psychiatric Unit due to an acute mania episode.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690248

Locations
Spain
Research Site
Alcoy, Spain
Research Site
Algeciras, Spain
Research Site
Almeria, Spain
Research Site
Barcelona, Spain
Research Site
Burgos, Spain
Research Site
Cordoba, Spain
Research Site
Granada, Spain
Research Site
La Coruna, Spain
Research Site
Las Palmas, Spain
Research Site
Logrono, Spain
Research Site
Madrid, Spain
Research Site
Malaga, Spain
Research Site
Murcia, Spain
Research Site
Osuna, Spain
Research Site
Oviedo, Spain
Research Site
Palma de Mallorca, Spain
Research Site
Pamplona, Spain
Research Site
Plasencia, Spain
Research Site
Ponferrada, Spain
Research Site
Pontevedra, Spain
Research Site
Salamanca, Spain
Research Site
San Juan (Alicante), Spain
Research Site
Sant Boi de Llobregat, Spain
Research Site
Santander, Spain
Research Site
Santiago de Compostela, Spain
Research Site
Sevilla, Spain
Research Site
Tenerife, Spain
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Teruel, Spain
Research Site
Toledo, Spain
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Valencia, Spain
Research Site
Valladolid, Spain
Research Site
Vitoria, Spain
Research Site
Zamora, Spain
Research Site
Zaragoza, Spain
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: Teresa Díez, PhD, Local MC Neuroscience Therapeutic Area Manager, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00690248     History of Changes
Other Study ID Numbers: NIS-NES-DUM-2007/5
Study First Received: June 2, 2008
Last Updated: December 7, 2010
Health Authority: Spain: NA

Keywords provided by AstraZeneca:
Acute mania
Bipolar disorder
depressive symptoms
mixed mania

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014