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

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

This study is not yet open for participant recruitment.

Verified by AstraZeneca, April 2009

First Received: April 24, 2009 No Changes Posted

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00888264

Purpose

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.

Condition
Bipolar Disorders

MedlinePlus related topics: Bipolar Disorder Depression

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Details of any AAP prescribed 1 to 6 months prior to the first study visit: [ Time Frame: 4 visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Young Mania Rating Scale (YMRS), an 11-point observer rating scale, used to assess the symptoms and severity of mania. [ Time Frame: 4 visits ] [ Designated as safety issue: No ]
Remission rate for the major depressive episode, in progress at inclusion [ Time Frame: At completion ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	May 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888264

Contacts

Contact: AstraZeneca Belgium Clinical Study Information

+3223704811

frederic.bellemans@astrazeneca.com

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( MCMD )
Study ID Numbers:	NIS-NBE-SER-2008/1
Study First Received:	April 24, 2009
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00888264 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AstraZeneca:

Antipsychotics
Bipolar Disorder
Depressive episodes
Bipolar I or II Disorders

Study placed in the following topic categories:

Affective Disorders, Psychotic
Tranquilizing Agents
Depression
Mental Disorders
Bipolar Disorder

Psychotropic Drugs
Mood Disorders
Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents

Pharmacologic Actions
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009