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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01663974
Recruitment Status : Terminated
First Posted : August 14, 2012
Last Update Posted : March 9, 2015
Information provided by (Responsible Party):

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).

Condition or disease
Bipolar Disorder Sub-syndromal Symptoms

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

Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder
Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Bipolar disorder patients

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. 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 ]
  3. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
hospital/medico-psychological centre (CMP) [clinic] / private practice

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01663974     History of Changes
Other Study ID Numbers: NIS-NFR-XXX-2012/1
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015

Keywords provided by AstraZeneca:
Bipolar Disorders
Sub-syndromal symptoms
Acute depressive episode
Symptomatic remission
Functioning remission

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders