Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder

Terminated

• Conditions: Bipolar Disorder; Sub-syndromal Symptoms

• Registration Number: NCT01663974
• Lead Sponsor: AstraZeneca

Brief Summary

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).

Detailed Description

Evaluation of sub-syndromal symptoms after acute depressive episode in bipolar disorder

Study Timeline

• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-14
• Study Start: 2013-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Adult patient with a diagnosis of bipolar disorder according to DSM-IV criteria currently followed up by the investigator in hospital or open-care practice and informed of his/her disease.
• For whom the previous episode was a bipolar depression assessed clinically stabilized for at least 4 weeks by the investigator.
• Able to complete the self-assessment diary weekly

Exclusion Criteria

• Pregnant women.
• Patient included in a clinical trial on an investigational drug or having received an investigational drug in the preceding 30 days.
• Person deprived of freedom or subject to a guardianship (or ward) order or unable to undergo medical monitoring for geographical, social or psychological reasons.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	12 months	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

Name	Time	Method
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.	12 months
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.	12 months
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.	12 months	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.

Trial Locations

Locations (1)

Research Site; 🇫🇷 Vincennes, France