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

Study Overview
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Brief Summary
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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
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Evaluation of sub-syndromal symptoms after acute depressive episode in bipolar disorder

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

Conditions
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Bipolar Disorder, Sub-syndromal Symptoms

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bipolar disorder patients<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorders, Sub-syndromal symptoms, Acute depressive episode, Symptomatic remission, Functioning remission