A NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00888264

Acronym

HARMONY

Enrollment

152

Registered

2009-04-27

Start date

2009-05-31

Completion date

2010-08-31

Last updated

2010-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorders

Keywords

Antipsychotics, Bipolar Disorder, Depressive episodes, Bipolar I or II Disorders

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Details of any AAP prescribed 1 to 6 months prior to the first study visit:	4 visits

Secondary

Measure	Time frame
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

Countries

Belgium

Outcome results