Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-10-31

Brief Summary

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This study aims to study prospectively for 8 months a sample of bipolar patients with acute depressive episode in order to identify that factors associated with functional impairment, with especial attention to the presence of subsyndromal symptoms beyond the acute phase.

Detailed Description

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Conditions

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Bipolar Disorder Bipolar Depression

Keywords

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Bipolar depression subsyndromal symptoms functioning cognitive function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Diagnosed with bipolar I or II disorder, and with an acute episode of bipolar depression at inclusion

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Bipolar Disorder I or II (DSM-IV-TR)
* Acute depressive episode at inclusion

Exclusion Criteria

* Inability (in investigator´s opinion) to carry out the follow-up plan
* Patients participating or having participated within previous 6 months, in clinical trials
* Mental retardation or any other medical condition affecting cognitive performance

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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NIS-NES-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id

Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

AstraZeneca

Responsible Party

Locations

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Countries

Other Identifiers

NIS-NES-DUM-2010/1