Clinical trial NCT00888264: A NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder
Official title: A 6 Month Observational Multicentric Prospective Study Observing the Use of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder, in the Course of a Major Depressive Episode
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorders
Keywords: Antipsychotics
Bipolar Disorder
Depressive episodes
Bipolar I or II Disorders
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-27
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients (male or female), diagnosed with Bipolar I or II disorder, having presented or presenting a major depressive episode (according to DSM-IV-TR) with starting date of 6 months maximum before the inclusion.

Brief summary: The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and clinical evaluation will be recorded and potential differences that may exist due to epidemiological factors or comorbidities will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Outpatients, diagnosed with Bipolar I or II Disorder, having presented or presenting a major depressive episode (according to DSM-IV-TR) with a starting date of 6 months maximum before the inclusion.
* Current treatment with atypical antipsychotic(s) (AAP(s)) minimal 1 month and maximum 6 months prior to the first study visit
* Patient takes an AAP at an adequate therapeutic dose as indicated in the local Summary of Product Characteristics (SPC) and current medical practice

Exclusion Criteria:

* Patients diagnosed with Bipolar I or II, experiencing a hypomanic, manic or mixed episode at time of inclusion
* Pregnant or breastfeeding women, or women of childbearing potential not using a medical reliable method of contraception as stated in the SPC of the AAPs

Primary outcomes:
measure: Details of any AAP prescribed 1 to 6 months prior to the first study visit:
timeFrame: 4 visits
Secondary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS), a 10-point observer rating scale, used to assess the symptoms and severity of depression.
timeFrame: 4 visits
measure: Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania.
timeFrame: 4 visits
measure: Remission rate for the major depressive episode, in progress at inclusion
timeFrame: At completion
Other outcomes:
Locations:
city: Aarschot
country: Belgium
facility: Research Site
city: Afsnee
country: Belgium
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Asse
country: Belgium
facility: Research Site
city: Berchem
country: Belgium
facility: Research Site
city: Bertrix
country: Belgium
facility: Research Site
city: Bierbeek
country: Belgium
facility: Research Site
city: Bouge
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Courtrai
country: Belgium
facility: Research Site
city: Dave
country: Belgium
facility: Research Site
city: Dendermonde
country: Belgium
facility: Research Site
city: Elsene
country: Belgium
facility: Research Site
city: Erpe Mere
country: Belgium
facility: Research Site
city: Geel
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Ixelles
country: Belgium
facility: Research Site
city: Kortenberg
country: Belgium
facility: Research Site
city: Laeken
country: Belgium
facility: Research Site
city: Lebbeke
country: Belgium
facility: Research Site
city: Lede
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Libramont
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Lierneux
country: Belgium
facility: Research Site
city: Lubbeek
country: Belgium
facility: Research Site
city: Malle
country: Belgium
facility: Research Site
city: Marchienne-au-pont
country: Belgium
facility: Research Site
city: Mons
country: Belgium
facility: Research Site
city: Montignies-sur-sambre
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Ottignies
country: Belgium
facility: Research Site
city: Roselaere
country: Belgium
facility: Research Site
city: Saint-Servais
country: Belgium
facility: Research Site
city: Sint-Josse-ten-Noode
country: Belgium
facility: Research Site
city: Sint-Martens-Latem
country: Belgium
facility: Research Site
city: Sint-Niklaas
country: Belgium
facility: Research Site
city: Sleidinge
country: Belgium
facility: Research Site
city: St Denijs Westrem
country: Belgium
facility: Research Site
city: St-Truiden
country: Belgium
facility: Research Site
city: Tienen
country: Belgium
facility: Research Site
city: Tournai
country: Belgium
facility: Research Site
city: Zottegem
country: Belgium
facility: Research Site
city: Zoutleeuw
country: Belgium
facility: Research Site
Study officials:
References: