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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01663974
First received: August 7, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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
Bipolar Disorder
Sub-syndromal Symptoms

Study Type: Observational
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 ]

Enrollment: 125
Study Start Date: April 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bipolar disorder patients

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

hospital/medico-psychological centre (CMP) [clinic] / private practice

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663974

  Show 86 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: J M AZORIN, Professor Hopital Sainte Marguerite - MARSEILLE - FRANCE
Study Director: A SOLVET, Doctor AstraZeneca - FRANCE
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01663974     History of Changes
Other Study ID Numbers: NIS-NFR-XXX-2012/1
Study First Received: August 7, 2012
Last Updated: February 3, 2014
Health Authority: France: National Consultative Committee on Treatment information for Health and Life Sciences : CCTIRS (Comite Consultatif sur le Traitement de l'Information en matiere de Recherche dans le domaine de la Sante)
France : French Data Privacy Authority
France: French Doctors Governing Body

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

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 22, 2014