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OpenTrials
Completed

NCT Number: NCT00690248

Depressive Symptoms in Acute Manic Episode

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Score of the MADRS (Montgomery-Asberg Depression Rating Scale) in bipolar patients with acute mania.

    Time frame: once during study

Secondary outcomes

  1. Mania symptoms measured with YMRS (Young Mania Rating Scale).

    Time frame: once during study

  2. Anxiety symptoms measures with HARS (Hamilton Anxiety Rating Scale).

    Time frame: once during study

  3. Psychotic symptoms measured with BPRS (Brief Psychosis Rating Scale).

    Time frame: once during study

  4. Clinical status and improvement measured with CGI-BP (Clinical Global Impression - Bipolar scale).

    Time frame: once during study

  5. Days of hospitalization, MADRS (6 items)

    Time frame: once during study

  6. Hamilton Depression Rating Scale (5 items)

    Time frame: once during study

  7. Scale of Unawareness of Mental Disorders (SUMD)

    Time frame: once during study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: MM1

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2008
Registry last updated
Dec 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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