Text Size

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

This study is currently recruiting participants.
Verified April 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01663974
First received: August 7, 2012
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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 ]
    MADRS will evaluate the severity of depressive states, YMRS scale will evaluate manic severity and MVAS-BP will evaluate the severity of mixed states. The 10 items of the Montgomery-Asberg Depression Rating Scale (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. Young Mania Rating Scale (YMRS) 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. Multiple Visual Analogue Scales for Bipolarity (MVAS-BP)questionnaire is composed of 26 visual analogue scales (VAS), 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 ]

Estimated Enrollment: 600
Study Start Date: April 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663974

Contacts
Contact: AstraZeneca Clinical Study Information 8002369933 information.center@astrazeneca.com
Contact: Sandrine Geha +33141294000 sandrine.geha@astrazeneca.com

  Show 79 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: J M AZORIN, Professor Hopital Sainte Marguerite - MARSEILLE - FRANCE
Study Director: M LUKASIEWICZ, 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: April 10, 2013
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
Depression
Depressive Disorder
Affective Disorders, Psychotic
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013