NCT00888264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Geographic Reach
1 country

45 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 22, 2010

Status Verified

December 1, 2010

Enrollment Period

1.3 years

First QC Date

April 24, 2009

Last Update Submit

December 21, 2010

Conditions

Bipolar Disorders

Keywords

AntipsychoticsBipolar DisorderDepressive episodesBipolar I or II Disorders

Outcome Measures

Primary Outcomes (1)

  • Details of any AAP prescribed 1 to 6 months prior to the first study visit:

    4 visits

Secondary Outcomes (3)

  • Montgomery Asberg Depression Rating Scale (MADRS), a 10-point observer rating scale, used to assess the symptoms and severity of depression.

    4 visits

  • Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania.

    4 visits

  • Remission rate for the major depressive episode, in progress at inclusion

    At completion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

Research Site

Aarschot, Belgium

Location

Research Site

Afsnee, Belgium

Location

Research Site

Antwerp, Belgium

Location

Research Site

Asse, Belgium

Location

Research Site

Berchem, Belgium

Location

Research Site

Bertrix, Belgium

Location

Research Site

Bierbeek, Belgium

Location

Research Site

Bouge, Belgium

Location

Research Site

Bruges, Belgium

Location

Research Site

Brussels, Belgium

Location

Research Site

Dave, Belgium

Location

Research Site

Dendermonde, Belgium

Location

Research Site

Erpe Mere, Belgium

Location

Research Site

Geel, Belgium

Location

Research Site

Ghent, Belgium

Location

Research Site

Hasselt, Belgium

Location

Research Site

Ixelles-Elsene, Belgium

Location

Research Site

Kortenberg, Belgium

Location

Research Site

Kortrijk, Belgium

Location

Research Site

Laken, Belgium

Location

Research Site

Lebbeke, Belgium

Location

Research Site

Lede, Belgium

Location

Research Site

Leuven, Belgium

Location

Research Site

Libramont, Belgium

Location

Research Site

Lierneux, Belgium

Location

Research Site

Liège, Belgium

Location

Research Site

Lubbeek, Belgium

Location

Research Site

Malle, Belgium

Location

Research Site

Marchienne-au-Pont, Belgium

Location

Research Site

Mons, Belgium

Location

Research Site

Montignies-sur-Sambre, Belgium

Location

Research Site

Namur, Belgium

Location

Research Site

Ottignies, Belgium

Location

Research Site

Roselaere, Belgium

Location

Research Site

Saint Denijs Westrem, Belgium

Location

Research Site

Saint-Servais, Belgium

Location

Research Site

Sint-Josse-ten-Noode, Belgium

Location

Research Site

Sint-Martens-Latem, Belgium

Location

Research Site

Sint-Niklaas, Belgium

Location

Research Site

Sleidinge, Belgium

Location

Research Site

St-Truiden, Belgium

Location

Research Site

Tienen, Belgium

Location

Research Site

Tournai, Belgium

Location

Research Site

Zottegem, Belgium

Location

Research Site

Zoutleeuw, Belgium

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

May 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 22, 2010

Record last verified: 2010-12

Locations

BE(45)