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

AstraZeneca

Status: Completed

Conditions: Bipolar Disorder; Bipolar Depression

Study type: Observational

Funder types: Industry

Identifiers

NCT01255982

NIS-NES-DUM-2010/1

Details and patient eligibility

About

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.

Enrollment: 249 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

249 participants in 1 patient group

1

Description:

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