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

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.

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Key information

Conditions

Bipolar Disorders Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aarschot, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 4 visits

Secondary outcomes

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

Time frame: 4 visits
Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania.

Time frame: 4 visits
Remission rate for the major depressive episode, in progress at inclusion

Time frame: At completion

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: HARMONY

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Apr 27, 2009
Registry last updated: Dec 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed