Depressive Symptoms in Acute Manic Episode (MM1)
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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 |
|---|
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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 |
- 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 ]
- 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.
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Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
bipolar patients admitted to a psychiatric Unit due to an acute mania episode.
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| Spain | |
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| Alcoy, Spain | |
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| Algeciras, Spain | |
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| Almeria, Spain | |
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| Barcelona, Spain | |
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| Burgos, Spain | |
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| Cordoba, Spain | |
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| Granada, Spain | |
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| La Coruna, Spain | |
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| Las Palmas, Spain | |
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| Logrono, Spain | |
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| Madrid, Spain | |
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| Malaga, Spain | |
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| Murcia, Spain | |
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| Osuna, Spain | |
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| Oviedo, Spain | |
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| Palma de Mallorca, Spain | |
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| Pamplona, Spain | |
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| Plasencia, Spain | |
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| Ponferrada, Spain | |
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| Pontevedra, Spain | |
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| Salamanca, Spain | |
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| San Juan (Alicante), Spain | |
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| Sant Boi de Llobregat, Spain | |
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| Santander, Spain | |
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| Santiago de Compostela, Spain | |
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| Sevilla, Spain | |
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| Tenerife, Spain | |
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| Teruel, Spain | |
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| Toledo, Spain | |
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| Valencia, Spain | |
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| Valladolid, Spain | |
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| Vitoria, Spain | |
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| Zamora, Spain | |
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| Zaragoza, Spain | |
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:
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Acute mania Bipolar disorder depressive symptoms mixed mania |
Additional relevant MeSH terms:
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Bipolar Disorder Depression Affective Disorders, Psychotic |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013