Functional Assessment of Patients With Acute Bipolar Depression After 8 Months of Follow-up
Completed
- Conditions
- Bipolar DisorderBipolar Depression
- Registration Number
- NCT01255982
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference between basal and final Functional Assessment Staging (FAST) score to evaluate the functional change Range of Days 0-3
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇪🇸Zaragoza, Spain