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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01255982

Enrollment

249

Registered

2010-12-08

Start date

2011-03-31

Completion date

2012-10-31

Last updated

2012-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Depression, Bipolar Disorder

Keywords

Bipolar depression, subsyndromal symptoms, functioning, cognitive function

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change	Range of Days 0-3

Secondary

Measure	Time frame
FAST score to estimate the proportion of patients that not achieve functional remission	Range of Days 0-3
Test Screen for Cognitive Impairment in Psychiatry (SCIP) to evaluate cognitive impairment both in the depressive phase and during clinical remission	Range of Days 0-3
Mood chart (self-report)	Range of Days 0-3
The presence of subsyndromal symptoms after the acute depressive phase using Montgomery-Asberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Diagnostic and Statistical Manual of Mental disorders (DSM-IV-TR)	Range of Days 0-3

Countries

Spain

Outcome results