Clinical trial NCT01255982: Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
Official title: Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Bipolar Depression
Keywords: Bipolar depression
subsyndromal symptoms
functioning
cognitive function
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-08
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients from Mental Health Centres or Psychiatric Offices, diagnosed with bipolar I or II disorder experiencing an acute depressive episode.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change
timeFrame: Range of Days 0-3
Secondary outcomes:
measure: FAST score to estimate the proportion of patients that not achieve functional remission
timeFrame: Range of Days 0-3
measure: Test Screen for Cognitive Impairment in Psychiatry (SCIP) to evaluate cognitive impairment both in the depressive phase and during clinical remission
timeFrame: Range of Days 0-3
measure: Mood chart (self-report)
timeFrame: Range of Days 0-3
measure: 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)
timeFrame: Range of Days 0-3
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Research Site
state: Alicante
city: Villajoyosa
country: Spain
facility: Research Site
state: Alicante
city: Sama de Langreo
country: Spain
facility: Research Site
state: Asturias
city: Granollers
country: Spain
facility: Research Site
state: Barcelona
city: San Boit de LLobregat
country: Spain
facility: Research Site
state: Barcelona
city: Monforte de Lemos
country: Spain
facility: Research Site
state: Lugo
city: Tudela
country: Spain
facility: Research Site
state: Navarra
city: Mos
country: Spain
facility: Research Site
state: Pontevedra
city: Catarroja
country: Spain
facility: Research Site
state: Valencia
city: Almería
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Lerida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Orense
country: Spain
facility: Research Site
city: Palencia
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zamora
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
References: