Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder (POLARIS)
This study has been terminated.
Information provided by (Responsible Party):
First received: August 7, 2012
Last updated: February 3, 2014
Last verified: February 2014
The study aims to evaluate:
- the frequency of subsyndromal symptoms or disorders observed during interepisode phases in bipolar patients, particularly after a depressive episode in which these subsyndromal disorders are the most frequent
- the functional impact of these disorders, factors or symptom thresholds associated with functional remission, and factors associated with symptomatic remission over a sufficient follow-up (12 months).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder|
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- The prevalence of sub-syndromal symptoms after an acute depressive episode in Bipolar Disorder patients, as measured by scoring on YMRS and MADRS scales and MVAS-BP self-administered questionnaire. [ Time Frame: 12 months ] [ Designated as safety issue: No ]The 10 items of the MADRS are scored as 0, 2, 4 and 6 (0 = no depressive symptoms; 6 = severe depressive symptoms). Total scores, ranging from 0 to 60, will be calculated by adding the values for the 10 items. The YMRS scale is composed of 11 items, scored from 0 to 4 (0 = no manic symptoms; 4 = severe manic symptoms). Total scores will be calculated by adding the scores for the 11 items. MVAS-BP questionnaire is composed of 26 visual analogue scales, each item is scored from 0 (extreme depressive pole) to 100 (extreme manic pole). Absence of symptoms is at the middle of the scale (value 50).
Secondary Outcome Measures:
- Impact of sub-syndromal symptoms on functioning of real-life French Bipolar Disorder patients as measured by scoring on Functioning Assessment Short Test (FAST) scale. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Functioning Assessment Short Test (FAST) is a brief instrument designed to assess the main functioning problems experienced by psychiatric patients. The 24 items of the FAST questionnaire are scored from 0 to 3 (a score of 0 indicates that the patient does not experience any difficulties, while a score of 3 indicates that the patient experiences major difficulties). Total scores will be calculated by adding the scores for each item. Functional remission will be evaluated on the FAST scale ; functional remission will be defined as a score < 11 on the FAST questionnaire.
- Number and type of factors associated with a symptomatic and functioning remission after recovery from an acute depressive bipolar episode in real-life French population. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Description of the management patterns (such as number and drug-class of treatments, number and type of resource used) associated with the presence and absence of sub-syndromal symptoms after an acute bipolar depressive episode. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Bipolar disorder patients|
Evaluation of sub-syndromal symptoms after acute depressive episode in bipolar disorder
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663974
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Sponsors and Collaborators
|Principal Investigator:||J M AZORIN, Professor||Hopital Sainte Marguerite - MARSEILLE - FRANCE|
|Study Director:||A SOLVET, Doctor||AstraZeneca - FRANCE|